Quality Assurance Specialist, I

Position Summary
This position conducts day-to-day QA/manufacturing support activities, including batch record review, media disposition, label issuance, archiving, and final product packaging and release. Must be able to gown into classified manufacturing ISO 7 clean room areas to inspect final product.

Responsibilities
- Perform and ensure batch record review and release of intermediates within SOP timeframes.
- Package and complete final batch disposition.
- Inspect final product within an ISO 7 cleanroom.
- Support day-to-day operations: batch record review, label issuance, archiving, and timely verification with supervision oversight.
- Follow oral and written procedures for review and release of intermediate and final product.
- Support projects as a QA resource.
- Identify deficiencies; coordinate with cross-functional departments to resolve.
- Identify issues and recommend process improvements.
- Revise Standard Operating Procedures.
- Other duties as assigned.

Basic Qualifications
- High school degree/GED with 2 years relevant pharmaceutical/biotech experience, or Bachelor’s with 0–1 years relevant experience.
- Basic working knowledge of GMP regulations.

Preferred Qualifications
- Strong written and verbal communication.
- Strong organization and time management.
- Proficient in MS Word and Excel.
- Experience with electronic batch records, ERP systems, and Quality Management Systems (e.g., TrackWise, Veeva).

Working Conditions/Physical Demands
- Lift/transport up to 30 lbs.
- Work one weekend day and support rotating holiday coverage.
- Gown into ISO 7 clean room and CNC areas.