Quality Assurance Release Coordinator
1 month ago
JOB SUMMARY
The Coordinator is responsible for performing duties and assisting the Manager, Quality Assurance with product disposition functions, encompassing the review of production batch records and the associated documentation required to release a production lot. He/she ensures compliance to product specification, good documentation practices, data entry, completeness of COAs, Company SOPs and cGMPs reviewing all documents from Production, Quality Control Laboratory, Quality Assurance and/or other related documents to a batch. The completed production batch (finished product) does not release from the building without the incumbent’s approval to prevent distribution of non-conforming products to customers. A similar release process is followed with the review of the raw materials sampling, testing, approve and/or reject activities.
ESSENTIAL JOB FUNCTIONS
1. Coordinates the assembly of batch information generated by Quality Assurance, Production, Manufacturing and Quality Control Departments.
2. Reviews and audits batch records. Collects data for trending performance measurements.
3. Makes final decision on product release, in absence of discrepancies.
4. Coordinate correction of documentation errors with appropriate department(s); and notifies management of batch record errors.
5. Notifies management of discrepancies and documentation errors with batch records.
6. Verifies counts of finished products prior to release. Notifies production of count discrepancies.
7. Prepares release or quarantine notices/stickers for in-process batches and finished products.
8. Maintains the quarantine hold area.
9. Performs transactions in Adage system.
10. Troubleshoots quality issues and initiates non-conformance investigations and deviations, as needed.
11. Collects information for investigations of quality issues.
12. Maintains the deviation files and deviation log.
13. Maintains all in process batch files. Archives all completed batch records.
14. Provides customers with Certificates of Compliance and Certificates of Analysis when necessary.
15. Proficient at reading, reviewing, and auditing documents and follow procedures.
16. Mastered the understating of Batch documentation requirements and all associated production and compliance steps.
17. Proficient at understanding, reviewing, and auditing all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, batch records, deviations, non-conformances etc.)
ADDITIONAL RESPONSIBILITIES
1. Participates in cGMP compliance audits and other committees, as required by the Manager, Quality Assurance.
2. Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance (e.g. serves as back-up to Inspector, Quality Assurance and Inspector, Receipt).
3. Supports the Winner’s Circle and Blistex Quality processes.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS
1. High School Diploma or GED with 4-6 years of applicable Quality Assurance environment preferable in the cosmetics/pharmaceutical OTC industry.
2. Bachelor's degree in Chemistry, Biology, or related scientific discipline with 2-3 years of applicable Quality Assurance environment preferable in the cosmetics/pharmaceutical OTC industry.
3. Must demonstrate effective communication skills for interactions with Quality colleagues, and colleagues from numerous functional areas.
4. Must listen actively and readily assumes responsibility for actions. Capable of managing tactical steps to push tasks forward.
5. Proficient at reading, reviewing, and auditing documents and follow procedures.
6. Mastered the understating of Batch documentation requirements and all associated production and compliance steps.
7. Proficient at understanding, reviewing, and auditing all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, batch records, deviations, non-conformances etc.)
8. Firm understanding of the organization QMS for retrieval requirements, retrieve essential records, following record keeping procedures.
9. Solid ability to detect errors in production documents reviews, deviations files, all quality documents support product release.
10. Master the understanding of "deals" associated with various markets and the cGMP requirements associated with the production and Quality life-cycle of a OTC drug.
11. Solid understanding of technical requirements for all quality documentation supporting batch production documents and their lifecycle.
12. Firm understanding of the Stability program/schedule and the compliance requirements associated with them.
13. Firm understanding of the departmental compliance role and responsibilities.
14. Master the ability to plan, organize and complete concurrent tactical tasks independently.
15. Ability to plan, organize and complete strategic Departmental tasks independently.
16. Firm understanding of the calculations as required in Production and Quality Assurance SOPs and in performing basic statistical calculations related to % Difference, Average, Standard Deviation, % RSD.
17. Understanding of how to review data for calculation errors and how to interpret data under supervision. Assist in writing deviations, non-conformances, and investigational reports.
18. Firm understanding of the company nonconformance SOPs and assist with performing the investigations.
19. Firm understanding of Quality and Compliance requirements while mastering the ability to identify deficiencies in Quality and Production documentation.
20. Ability to understand the requirements of a good investigation and/or deviation.
21. Considerable interpersonal skills are required to interact with various levels of internal and external customers.
22. Must possess the ability to prepare detailed and accurate documentation.
23. Good organizational ability and detail minded.
24. Must possess ability to work independently on a multitude of concurrent tasks.
25. Must be discreet with confidential information of which he/she has access.
26. Must possess high degree of familiarity with and ability to use office machines.
27. Willingness to accept other duties, as assigned.
28. Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management and comply with Company policies.
-
Quality Assurance Manager
3 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations...
-
Quality Assurance Associate III
3 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...
-
Quality Assurance Specialist
4 days ago
Oak Brook, Illinois, United States Integrated Talent Strategies Full timeIntegrated Talent Strategies (ITS) is in search of a Quality Assurance Specialist to join a prominent engineering and consulting firm. This role presents an array of excellent benefits, including a competitive salary, comprehensive health coverage, a 401(k) plan, and generous paid time off.QualificationsBachelor's degree in Engineering, Quality, or a related...
-
Quality Assurance Specialist
2 months ago
Oak Ridge, United States Edgewater Federal Solutions, Inc. Full timeThis position will provide expertise to the U.S. Department of Energy (DOE) Office of Scientific and Technical Information (OSTI) related to the software quality assurance of OSTI-built web applications, including a major electronic workflow system for scientific and technical information and multiple public-facing search portals for dissemination of...
-
IT Quality Assurance Specialist
1 month ago
Oak Ridge, United States Edgewater Federal Solutions, Inc. Full timeThis position will provide expertise to the U.S. Department of Energy (DOE) Office of Scientific and Technical Information (OSTI) related to the software quality assurance of OSTI-built web applications, including a major electronic workflow system for scientific and technical information and multiple public-facing search portals for dissemination of...
-
BI Quality Assurance Analyst
1 month ago
Oak Brook, United States Radiological Society of North America Full timeWhat we’re looking for: The BI Quality Assurance Analyst role is to implement quality assurance standards for the Agile Data Team in the Agile format. This position will be focused on Datasets and Report testing. This individual will apply proven analytical and critical thinking skills to perform testing of reports and data. This individual will also...
-
Quality Assurance Inspector I
4 weeks ago
Oak Brook, United States Blistex Full time3rd shift: 10pm - 6:30amJOB SUMMARY The Quality Assurance Inspector I can have responsibilities in two areas: QA Receipt Inspection and QA Production Inspection. The position is responsible for sampling and inspecting incoming packaging and chemical raw materials for conformance to regulatory and Company standards. He/she ensures that everything required to...
-
Quality Assurance Inspector I
4 weeks ago
Oak Brook, United States Blistex Inc Full timeJob DescriptionJob Description3rd shift: 10pm - 6:30amJOB SUMMARYThe Quality Assurance Inspector I can have responsibilities in two areas: QA Receipt Inspection and QA Production Inspection. The position is responsible for sampling and inspecting incoming packaging and chemical raw materials for conformance to regulatory and Company standards. He/she ensures...
-
Quality Assurance Auditor
2 months ago
Bound Brook, United States Paragon Staffing, LLC Full timeJob DescriptionJob DescriptionParagon Staffing, LLC is a company that specializes in connecting job seekers with employers who are seeking temporary, contract, or permanent positions.Due to the growth, Paragon Staffing, LLC is looking for Quality Assurance Auditors to join our team! Summary: Quality Auditors oversee testing to ensure that products meet...
-
Quality Control Manager
3 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily...
-
Quality Assurance Compliance Investigator
3 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality...
-
Quality Assurance Manager
3 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight...
-
Brook Park, United States Gorton's Full timePosition SummaryThe Food Safety and Quality Assurance (FSQA) Sanitation Lead supports the FSQA team in maintaining key food safety, quality, and regulatory programs in support of a 24-hour dry mix operation. This position will lead all Sanitation programs for the facility and will work Monday through Friday, 10pm – 6:30am. The Sanitation Lead will manage...
-
Brook Park, United States Gorton's Full timePosition SummaryThe Food Safety and Quality Assurance (FSQA) Sanitation Lead supports the FSQA team in maintaining key food safety, quality, and regulatory programs in support of a 24-hour dry mix operation. This position will lead all Sanitation programs for the facility and will work Monday through Friday, 10pm – 6:30am. The Sanitation Lead will manage...
-
Brook Park, United States Gorton's Full timePosition SummaryThe Food Safety and Quality Assurance (FSQA) Sanitation Lead supports the FSQA team in maintaining key food safety, quality, and regulatory programs in support of a 24-hour dry mix operation.This position will lead all Sanitation programs for the facility and will work Monday through Friday, 10pm 6:30am.The Sanitation Lead will manage all...
-
Materials Quality Assurance Specialist
4 days ago
Pine Brook, United States Roeslein Full timeAbout Roeslein:Roeslein is a distinguished leader in the engineering and manufacturing sector, specializing in innovative solutions for the aerospace and defense industries. With a commitment to excellence and a legacy of over a century, we are dedicated to delivering high-quality products and services to our global clientele.Position Overview:The Materials...
-
Supplier Quality Assurance Engineer
4 days ago
Brook Park, Ohio, United States Actalent Full timePosition Title: Supplier Quality Assurance EngineerRole Overview: As a Supplier Quality Assurance Engineer, you will spearhead critical supplier processes aimed at enhancing Supplier Quality Reject (QR) performance metrics. Your involvement in Quality Reviews and participation in designated sub-system PRT (Powertrain Variability Reduction Team) meetings will...
-
Quality Assurance Auditor
1 month ago
Bound Brook, United States Paragon Staffing, LLC Full timeJob DescriptionJob DescriptionParagon Staffing, LLC is a company that specializes in connecting job seekers with employers who are seeking temporary, contract, or permanent positions.Summary: Quality Auditors oversee testing to ensure that products meet the established standards of appearance or performance. Conducting hourly inspections on parts to...
-
Quality Assurance Analyst
4 days ago
Oak Creek, Wisconsin, United States Compass Group Careers Full timeJob OverviewPosition: Quality Assurance TechnicianCompany: Compass GroupJob Summary:We are currently seeking dedicated individuals for the role of Quality Assurance Technician. This position is essential in ensuring the highest standards of quality and safety in our food production processes.Key Responsibilities:Conduct thorough quality assurance audits and...
-
Stony Brook, New York, United States Stony Brook University Full timeOncology Clinical Trials Quality Assurance CoordinatorRequired Qualifications: (as evidenced by an attached resume)A Bachelor's degree in business, science, or a related discipline (foreign equivalent or higher). A minimum of two (2) years of full-time direct experience in Quality Assurance for human research, including at least one (1) year of full-time...
