20 Quality Assurance jobs

The Sr. Quality Specialist, Training provides support to the Compliance Department and ensures compliance with cGMP and company policies, procedures and specifications. Specifically, the Sr. Specialist will be responsible for independently overall administration, execution, management, and maintenance of the training system, the specific details of which are as follows: ·                   Management, continual assessment and improvement of the training system and its compliance with cGMP. ·                   Provide subject matter expert (SME) support as needed for regulatory inspections and site Quality / Compliance efforts ·                   Training of Site Management and Training Coordinators on their roles and responsibilities in the training system ·                   Training of Training System assets (e.g. Quality Specialist, Training) ·                   Management, maintenance, and monitoring of training records, both electronically within ComplianceWire Learning Management System (LMS) as well as any paper based records. ·                   Reviewing and approving of quizzes prior to SOP promotion to training ·                   Assisting with the administrative setup of training sessions ·                   Facilitating and / or conducting cGMP training for the site (e.g. annual refreshers, new hire orientation) ·                   Conducting training with Certified Trainers including Train The Trainer ·                   Compilation of Training metrics for inclusion in QRB reports   Secondary responsibilities include assisting other aspects within the Compliance Department such as product complaint handling, vendor management, internal audits, and management of 3rd party, regulatory, or corporate inspections. The ideal candidate for this position should be comfortable in a public speaking environment as well as working one-on-one with individual Training Coordinators and Department Heads as primary contact for training related issues. Training System Administration: ·         Serve as the site Business System Administrator (BSA) for the site training system. ·         Serve as the site SME for the training system; present/explain the system during audits. ·         Serve as the primary point of contact for all training-related items for the department training coordinators; secondary point of contact for Certified Trainers and Department Management. ·         Manage Training records, both electronic and paper based. ·         Manage and conduct Introductory and Annual cGMP training sessions. ·         Conduct classroom training during new hire orientation, annual GMP and Certified Trainers certification courses. ·         Creation, implementation, management and maintenance of On-the-Job training program. ·         Administration of the Training Coordinator program. ComplianceWire Administration: ·         Train personnel on how to use the system. ·         Creation and maintenance of training curriculum / roles. ·         Creation of Training Items. ·         Review and approve quizzes associated with SOPs. ·         Review SOPs for clarity prior to promotion to training. ·         May serve as Training Coordinator for Compliance and Quality Systems department. ·         Author new or revise existing Compliance procedures (SOPs and Work Instructions) as needed. ·         Subject matter expert for the training system. ·         May develop a SOP training matrix and monitor training compliance against that program. ·         Actively identify opportunities and implement improvements to the training program (based on supervisors’ input, audit findings, current investigation trends, industry trends/practices, etc.). Owner of Training System Metrics: ·         Develop and monitor appropriate metrics to ascertain the effectiveness of the training. ·         Compile monthly and quarterly Training metrics for inclusion in QRB reports. May support/assist in other aspects within the Compliance Department such as: ·         Complaint handling ·         Vendor Management ·         Internal Audits ·         Coordination of Inspection Readiness logistic activities ·         Regulatory inspection support (e.g. War Room support, runner, scribe)   ·         Bachelor’s degree in a science discipline (Chemistry, Biology, Biochemistry, or Microbiology preferred) with a minimum of 6 years’ experience in a GMP environment is required. ·         Experience in employee training is required. Experience with administration of an electronic training management system strongly is desired.  ·         Strong knowledge of the 21 CFR Part 210 and 211, GDP and GMP. ·         Strong knowledge of FDA and GMP regulations. ·         Thorough knowledge of Company SOPs applicable to job. ·         In-depth knowledge of all applicable Instructional Design practices. Technical and quality background related to pharmaceuticals.

**MUST HAVE STRONG TECHNICAL WRITING SKILLS** The Quality Specialist serves as the Technical Writer in the Quality  Control department and is responsible for creating or revising laboratory  test monographs, protocols, reports, SOP’S and investigations in the electronic documentation (Master Control/TrackWise)systems.   Interacts frequently with Departmental leaders to provide perspective on timing of document needs such as test methods, specifications and controlled documents, change control, and FDA filings. Works collaboratively with Manufacturing/Pharm Tech/R&D and Regulatory affairs for revisions to records. May also participate in project teams for new product introductions.   Collaborations & Management of Manufacturing Batch Records § Works collaboratively with Manufacturing/Pharm Tech/R&D and Regulatory affairs for revisions to revising laboratory test monographs, protocols, reports, SOP’s and investigation records. § Interacts frequently with Departmental leaders to provide perspective on timing of test methods, specifications and controlled documents, change control, and FDA filings. § Maintains a schedule for completion of documents. § Revises records using the current validated EDMS/TrackWise and ensure consistency across the groups in laboratory. § Provides timely support and direction to the team and/or other departments in creating or updating Master P Records. § Maintains awareness to the document control needs of the Manufacturing department and other departments in order to meet scheduling needs. § Mutual Accountability to review and propose revisions to laboratory records and SOP's as required. Compliance § Identifies compliance risks to management, provides remediation proposals, and supports solution implementation for document control issues. § Provides compliance support, expertise, and training for all impacted departments. § Performs self-check audits and immediate support for regulatory audits. SOPs § Participates in the development of standard work practices and/or SOPs to ensure high and consistent level of quality. § Writes and revises SOPs as necessary. Continuous Improvement § Mutual accountability with other departmental leadership to improve document control and implement electronic database management systems (EDMS). § Participates in site quality improvement teams. § Seeks out improved EDMS systems for future use. § BS degree in Chemistry, Biology or Pharmaceutical Sciences with 3+ years’ experience in a pharmaceutical manufacturing environment including a minimum of 2 years in Quality/laboratory.    § Knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA. § Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines. § Technical and quality background related to pharmaceuticals. § Working knowledge of electronic batch record systems. § Strong communication skills. § Strong focus on quality and proven ability to apply a high degree of integrity. § Customer/Stakeholder focused (understand business plans and operating environment). § Demonstrated skills in document control and EDMS/TrackWise systems. § Strong technical writing ability. § Clear problem-solving and decision-making skill.

We are seeking people who can learn to run a production machine. We take corrugate paper and convert it into parts used to make displays for retail stores. Everyone starts with feeding the machine the paper and after time you are tough how to change the die cutters and set up for other jobs to run on the machine. You have to be able to write the count on packing cards.  You must be able to stand for long periods of time, bend, stoop, lift 25lbs or more, push and pull.  We are seeking people for 2nd and 3rd shifts.  We run a straight 8 hours shifts with 2 breaks. Bring food and drink.  Send me your resume if you are interested. 

Intertek,   a leading provider of   ATIC   (Assurance, Testing, Inspection and Certification) Services,   is looking for a   Technician to join our Building and Construction team in   Kent, WA.   The Technician will support the Building and Construction business by performing standard testing and evaluation on a variety of products and prepare technical reports. We’re looking for a detail oriented individual that will communicate with clients and project team regarding site observations, test preparation, procedures, results, and reporting matters Responsibilities:   Communicate with clients on test preparation, procedures, results, and reporting   Responsible for the testing of products in accordance with referenced specifications and procedures, including the concise and timely reporting of results and interfacing with the client, as well as the construction of test bucks and sampling of tested products when needed   Check Calibration status of test equipment prior to testing   Manage all jobs assigned to you through Oasis   Work with Supervisor, Project Engineers/Managers, and Technicians on major testing and research projects   Write testing report for the testing you have completed Requirements   High School Diploma or GED   A complete knowledge of all equipment, test methods, and applicable specifications associated with the areas of responsibility   Technical competency to effectively communicate test procedures, specifications, and results with customers    Familiarity with the Quality Control policies and procedures which relate to the control, storage, and disposition of test specimens   Ability to properly operate power tools and equipment necessary to complete assigned jobs   Physical ability to routinely lift at least 50 pounds and work from a step ladder   Expected to travel based on the needs of the business   Experience using Microsoft Word and have basic computer skills   Valid Drivers’ License and clean driving record

We are looking for Special Inspectors or Technician s that are certified in any of the following: ACI Level 2 or ICC Special Inspection or ICC Structural Masonry, ICC Structural welding, ICC Structural steel and bolting, ICC Reinforced Concrete or NICET asphalt, concrete or soils. You will observe contractors on construction sites and perform basic field and concrete tests under the direction of other technicians or engineering professionals to ensure that testing, sampling, or inspection is performed consistent with project specifications. With minimal paperwork involved, all observations and test data is input on smart phones in the field for immediate transmittal to our Project Managers for review.    Engineering background desired but not required. Position Responsibilities: Collect samples of concrete and construction materials in the field to measure physical characteristics Perform a variety of tests on construction materials including , aggregates, concrete/mortar/grout, using materials-testing equipment Read construction documents to determine project details and specifications Neatly and accurately complete all required paperwork, including daily reports, test reports and timesheets – in a timely manner Record and report test results after performing mathematical calculations, making graphical solutions and graphical representations Communicate orally and in writing with engineers and staff members, agency representatives, contractors and business and property owners Perform maintenance/cleaning of equipment and calibration and adjustments as need Adhere to construction site safety guidelines and promotes a safe working environment Comfortable using MS Office applications (Word/Excel/Outlook) Inspection of construction operations Must be punctual, reliable with good attention to detail Required Qualifications: Must be able to climb ladders, bend, crawl, push and pull, stretch, sit, walk and stand for extended periods of time. Must be able to lift up to 50lbs High school diploma or GED required

Structural Steele Inspector will perform welding & bolting inspections at various jobsites and steel fabrication facilities to ensure conformance to project specifications and building codes in NYC and the Tri-State metropolitan area. Requirements:   Must be AWS Certified Welding Inspector   ICC Certified Structural Steel & Bolting Inspector required or obtain within 90 days of hire   Must be able to climb ladders, bend, crawl, push and pull, stretch, sit, walk and stand for extended periods of time   Must have valid drivers’ license   Must be able to lift up to 50lbs   Salary commensurate with experience Position Responsibilities:   Read construction documents to determine project details and specification   Neatly and accurately complete all required paperwork, including daily reports, test reports and timesheets – in a timely manner   Record and reports test results after performing mathematical calculations, making graphical solutions and graphical representations   Communicate orally and in writing with engineers and staff members, agency representatives, contractors and business and property owners   Perform maintenance/cleaning of equipment and calibration and adjustments as needed   Adhere to construction site safety guidelines and promotes a safe working environment   Inspection of construction operations   Must be punctual and reliable with good attention to detail

Intertek,   a leading provider of   ATIC   (Assurance, Testing, Inspection and Certification) Services,   is looking for a   Technician III   to join our Building and Construction team   in St. Louis / Kansas City, MO .  The Technician III will support the Building and Construction business by conducting entry level testing projects on a variety of building products under direct supervision until signed off to perform testing independently. We’re looking for a technically inclined candidate who will follow and enforce all safety requirements and company policies while providing exceptional customer service. Duties   Manage all assigned jobs through QEST (proposals, job progress, job notifications, invoicing, documentation of test data, reporting, job closure)   Review and thoroughly understand contract requirements, and obtain authorization for and document any deviations   Coordinate test schedule with equipment schedule and other department testing   Track and condition test specimens   Set-up/mount and perform standard tests on building products in accordance with referenced specifications and procedures   Check calibration status of test equipment prior to testing   Analyze test results and write accurate and concise test reports that summarize the test procedures and results   Communicate with clients regarding test preparation, procedures, and results Requirements   High School Diploma or GED, Associate’s Degree in a technical field preferred or equivalent related experience   General construction/carpentry knowledge and experience using power tools   Technical competency to understand and communicate test procedures, specifications, and results and possess a mechanical aptitude   Familiarity or ability to learn Quality Assurance policies and procedures which relate to the control, storage, and disposition of test specimens   Physical ability to routinely lift at least 50 pounds   Physical ability to sit, stand, crouch, bend, climb stairs and ladders, crawl, push, pull, etc. as required to perform job duties   Ability to follow directions and work under supervision   Excellent customer service skills   Strong communication skills – both written and oral   Good computer skills using Word and Excel, and AutoCAD if applicable   Valid Drivers’ License and clean driving record   Ability to travel as business needs dictate

Intertek,   a leading provider of   ATIC   (Assurance, Testing, Inspection and Certification) Services,   is looking for an   Administrator   to join our Building and Construction team in   Kennesaw, GA .  The Administrator will support the Building and Construction business by actively partnering with and assisting the Area Managers/Directors with the administration of the multiple supplier qualification systems that client require us to submit information to and provide routine updates. We’re looking for a candidate who can follow and enforce all safety requirements and company policies while providing exceptional customer service Duties   Assist with tracking and trending of information related to safety issues   Assist with tracking, updating, processing controlled documents   Perform other work as required Requirements   High School Diploma or GED   Computer skills MS Word, MS Excel, etc.   Knowledge of ISO 17025 (ISO 9001), ISO 17020, and/or ISO 17065 requirements preferable   Understanding of specific processes relative to access of controlled documents and compliance with the quality management requirements   Basic understanding of the test, inspection, and evaluation procedures utilized by Intertek B&C   Competence to assist with the implementation and maintenance of the safety/quality system required by Intertek B&C’s various accreditations and training needs   Complete working knowledge of all computer software applications (MS Word, Excel, PowerPoint, Oasis, SharePoint, etc.) and office equipment used in the completion of the duties listed above   Strong written and oral communication skills   Ability to understand and interpret the requests of various clients and locate the information needed or find where it is located

Intertek, a leading provider of ATIC (Assurance, Testing, Inspection and Certification) Services, is looking for a  Manager  to join our Building and Construction team in  Kent, WA .  The Manager will support the Building and Construction business by coordinating, managing, monitoring, and expanding services of assigned Operational Unit. We’re looking for a candidate who can effectively manage a team while providing exceptional customer service.  The Lab Manager is in charge of the site (Site manager) supervises the site staff and is responsible for the site Profit and Loss (P&L manager).   Duties  Manage and mentor direct reports  Provide weekly revenue and expense forecasts  Interacts with clients and provide exceptional customer service  Research, assist in the development of, and promote new business opportunities  Interact with clients and provide exceptional customer service  Provide weekly revenue and expense forecasts the B&C leadership  Coordinate and dispatch staff and equipment to best utilize personnel and equipment  Follow and enforce all safety requirements and company policies Requirements  Bachelor’s Degree in Science or Business is preferred  5+ years supervisory or managerial experience in construction related business  Excellent communication and interpersonal skills  Proven leadership and team building skills  Technical competence to interpret and effectively communicate test procedures, specifications and results with team members, customers, consultants, and specifiers  Complete knowledge and understanding of all equipment, test methods / methodology and applicable specifications associated with areas of responsibility  Experience and skills that facilitates an understanding of computers and software to perform the job duties efficiently and effectively  Knowledge and understanding of project specification development, architectural drawings and shop drawings as they relate to the construction of a commercial building  Understanding of industry organizations involved in writing test methods and specifications  Ability to travel as business needs dictate  Valid Driver’s License and clean driving record

Intertek,   a leading provider of   ATIC   (Assurance, Testing, Inspection and Certification) Services,   is looking for a   Technician to join our Building and Construction team in   Plano, TX .  The Technician will support the Building and Construction business by setting up and performing tests on a variety of products including doors, windows and skylights. We’re looking for a candidate who has a can-do attitude, a strong technical ability and mechanical aptitude. This is a full-time, entry-level position that offers on-the-job training and excellent opportunities for growth.    Duties   Building and dismantling test chambers   Assisting the technician with running tests   Providing clients with excellent customer service Requirements   High school diploma or GED required   General construction and/or carpentry experience   Coursework in wood shop, math and general construction a plus   Ability to follow direction to work both independently and in a team environment   Overnight Travel up to 50% of time.    (Company paid travel and daily per diem provided)   Ability to climb ladders, bend, crawl, push, pull and perform physical labor   Ability to lift up to 75 pounds   Ability to pass a pre-employment, physical and drug screen

Intertek,   a leading provider of   ATIC   (Assurance, Testing, Inspection and Certification) Services,   is looking for a   Materials Lab Technician   to join our Building and Construction team in   York, PA .  We’re looking for a candidate who loves challenge and doesn’t like to be bored. Intertek's Materials Laboratory in York, PA conducts over 1,200 different tests (mechanical, durability, appearance, etc.) for the building & construction industry...and beyond! We are a third-party, independent test lab contracted by manufacturers to test their products for safety and code compliance. We like to say: “You build it and we'll break it”. This is a technical, hands-on position that requires physical labor to set up and perform tests on a variety of building products and components. This is an entry level position with on-the-job training provided; with excellent opportunities for growth and stability. Duties   Set-up and perform tests on building products in a laboratory and field environment   Analyze test results and write accurate and concise test reports that summarize the test procedures and results   Communicate with clients regarding test preparation, procedures, and results Requirements    High school diploma or GED   Associate’s Degree in a technical field is desired or equivalent experience   Technical competency to understand and communicate test procedures, specifications, measurements, and results   General lab and sample preparation knowledge and experience with various materials is desired   General measurement skills (tape measure, caliper, ruler, …)   Excellent customer service skills   Strong communication and organizational skills in a team environment   Good computer skills using Word and Excel   Ability to travel as needed   Valid Drivers’ License and clean driving record

We have an immediate opening in our Springdale, PA operation. The right candidate will have a “can-do” attitude with a strong technical ability and mechanical aptitude. This is a “hands-on" position that requires physical labor to setup and perform tests on a variety of products including doors, windows and skylights. This is a full-time position offering on-the-job training and excellent opportunities for growth.   RESPONSIBILITIES This position is responsible for setting up and performing tests on a variety of building products and components. This is an entry level position with on-the-job training provided. Listed examples are illustrative and representative of the tasks required of this position and are not intended to be complete or exclusive. Follow and enforce all safety requirements and company policies Provide exceptional customer service Take responsibility for testing projects under direct supervision as assigned, until signed off to perform testing independently Manage all assigned jobs through Oasis (proposals, job progress, job notifications, invoicing, documentation of test data, reporting, job closure) Review and thoroughly understand contract requirements, and obtain authorization for and document any deviations Coordinate test schedule with equipment schedule and other department testing Track and condition test specimens Set-up/mount and perform standard tests on building products in accordance with referenced specifications and procedures Check calibration status of test equipment prior to testing Analyze test results and write accurate and concise test reports that summarize the test procedures and results Communicate with clients regarding test preparation, procedures, and results Learn test standards and test procedures (e.g., AAMA, ASTM, NFPA, etc.) Assist in all areas of testing to gain experience Remove specimens and discard; store samples Perform shipping and receiving duties, as needed Maintain tools and equipment; inventory supplies; maintain cleanliness of work area Computer modelling of building mock-ups and test chambers, if designated as CAD operator Perform other work as required REQUIREMENTS High School Diploma or GED required Associate Degree in a technical field desired, or equivalent related experience   Must be technically competent to understand and communicate test procedures, specifications, and     results and possess a mechanical aptitude Must be familiar with (or possess the ability to learn) Quality Assurance policies and procedures which relate to the control, storage, and disposition of test specimens General construction/carpentry knowledge and experience using power tools Physical ability to routinely lift at least 50 pounds Physical ability to sit, stand, crouch, bend, climb stairs and ladders, crawl, push, pull, etc. as required to perform job duties Ability to follow directions and work under supervision Excellent customer service skills Strong communication skills – both written and oral Good computer skills using Word and Excel, and AutoCAD if applicable Ability to travel as business needs dictate