Senior Quality Assurance Associate
Senior Quality Assurance (QA) Associate
POSITION SUMMARY: The Senior Quality Assurance (QA) Associate will directly support the implementation, execution, and maintenance of Quality Systems to ensure Ash Stevens (ASH) complies with regulatory requirements as propagated by the United States Food and Drug Administration (USFDA) and other international regulatory authorities. Principle assignments related to compliance may include material release, review and implementation of new and revised documentation to support ASH Quality Systems and operations, internal and external audits, and training of ASH personnel to meet Good Manufacturing Process (GMP) requirements. The scope of this position will support both clinical and commercial manufacturing as well as process development in the Riverview facility.
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:
- Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
- Identify and protect the original technical information as part of the company property.
- Review of batch production records (including analytical test packages, cleaning records, etc.: The incumbent’s primary responsibility will be to ensure that batches meet GMP requirements and are manufactured according to approved Standard Operating Procedures (SOP), finished products meet specifications before releasing it to the client, and appropriate resolution to batches pending approval due to GMP errors and related corrective action investigations. Review in-process batch records, finished product batch records and intermediate analytical records. Release raw materials, starting materials, intermediate products, and final Active Pharmaceutical Ingredient (API) based upon conformance with specifications and completion of associated documents. In addition, when shipments of final API are made, verify labeling and packaging is consistent with ASH’s SOP.
- Administrative Duties: Issue master production records to manufacturing, ensuring that the current version is issued. File completed batch production records, testing records, and cleaning records. Maintain change control files for master records, SOPs, and forms. Ensure that current versions of the records are properly filed and available for use by the end users.
- Audits: Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during an audit. Conduct internal audits and housekeeping inspections and walkthrough’s of ASH Quality Systems and related operations to ensure compliance with written procedures. Audits quality system and records, creating documentation as needed. Follow-up as appropriate to ensure corrective action is implemented. During an audit of ASH, participate in the audit to explain ASH’s quality systems and operations. The incumbent is expected to represent ASH’s systems thoroughly and positively, being receptive to the auditor’s comments. Participate in the development of a formal response to audit report as appropriate. Maintain QA retain inventory and perform annual retain inspections.
- Reports/Document Management: This may include Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports. Participate in preparation or review of associated documentation, such as Analytical Methods Validation Reports, Cleaning Validation Reports, and Process Validation Reports.
- Quality Systems Support: Support tracking of Quality System deliverables, i.e. CAPA’s, periodic document review, environmental monitoring, Quality Metrics, Quality Agreements etc. Review and approve Trackwise events related to manufacturing, laboratory and warehouse operations. Participate in the evaluation and triage of events, deviations, CAPAs, OOS, OOT and unplanned maintenance activities. Identify and implement continuous improvements for the elements of the quality system related to manufacturing, laboratory and warehouse operations. Contribute to the writing, coordination, review, approval and maintenance of the standard operating procedures, policies and work instructions. Conduct Gap Assessments with corporate guidelines and regulatory requirements and develop mitigation plans
- Metrics: Perform routine and adhoc Quality Systems Metric Reporting and analysis for the local site data. Prepare metrics and perform trend analysis in support of management review.
- Risk Management: Participate in the Risk Management program, including updating risk analysis, participating in applicable teams and maintaining Risk Management documents.
- Training: Participate in training of ASH team members and in documentation and maintenance of training files. Conduct training activities related to QA operations and quality systems. Develop and maintain training modules.
- Bachelor’s degree in the physical or biological sciences or engineering. Chemistry/Chemical Engineering preferred.
- Minimum eight (8) years’ experience in pharmaceutical operations, regulated life sciences, or quality assurance, or an equivalent combination of Quality and technical education and experience is preferred with 2-5 years of supervisory experience.
- Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
- Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.
- Proficient in TrackWise, SAP and Master Control.