Quality Assurance Specialist, I

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

Qualifications:
- High school/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/Skills:
- Strong written/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).

Required Working Conditions/Physical Demands:
- Lift/transport up to 30 lbs; work one weekend day; support rotating holiday coverage.
- Gown into classified manufacturing ISO 7 cleanroom areas for final product inspection; gown into CNC areas.

Compensation:
- Hourly wage range: $28.85–$34/hour.