Biotech company in the Mid Atlantic biotech area is looking to hire a QA Supervisor to manage the daily activities of the QA Product Release department, ensuring all submitted documentation is reviewed in a timely manner. Proactively assesses and resolves problems by taking the appropriate actions to provide timely updates and communications to all necessary parties to meet established due dates. Manages the finished product review/release function to assure compliance with good documentation practices, good manufacturing practices and standard operating procedures.
typical roles and responsibilities for QA Supervisor
- Management and administration of the documentation related to, and personnel responsible for, the review, reconciliation and release processes.
- Work with management from Operations, Quality, and QC to ensure documents are completed and submitted to QA Batch Release on-time and in accordance with Good Documentation Practices and to resolve issues associated with the batch record documents.
- Performs QA Review for Batch Record lot release, ensuring paperwork is accurate and complete including lot numbers, labeling, artwork, revision numbers and all other documented specifications.
- Develop, maintain, and report to senior management Quality Metrics for product release.
- Provide training, guidance and coaching to internal and external customers.
- Supports internal and external audits as needed.
- Assist as needed with the quality system processes such as Non-Conforming Material (NCR), Corrective and Preventive Actions (CAPA).
- Compliance with established Company and departmental policies and procedures, objectives, quality assurance program, safety and environmental standards.
- Other duties as assigned as emerging growth company it may be required from time to time to assist in other areas other than the area of specialty.
Requirements for QA Supervisor – Scientific
- Undergraduate degree preferred and/or a minimum of 5 years detailed oriented work experience in a regulated environment required
- Strong knowledge of the FDA QSR’s as well as the point-of-care, in-vitro diagnostic (IVD). Knowledge of other country directives and regulations is highly preferred.
- Prior experience in the Medical Device and/or IVD industry experience highly preferred.
- Experience in supporting FDA and Notified Body Audits.
- Must possess excellent written and verbal communication skills.
- Experience with medical device and/or IVD manufacturing process qualifications/validations (IQ/OQ/PQ).
- Proficiency in Microsoft Word, Excel, Outlook and other office software programs. Knowledge of SolidWorks is a plus.