Senior Quality Assurance Specialist, On the floor (Overnights)

What You’ll Do:
- Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team
- Assess existing procedures/documents for suitability; where inadequate, identify path to establish procedures
- Develop, write, review, and approve SOPs, specifications, and other documents (operation/facility SOPs, quality training, batch documentation, etc.)
- Maintain project timelines
- Perform on-the-floor quality review of documents (equipment logs, training records, testing results, batch records and supporting documents)
- Review and approve documents (electronic and paper-based)
- Provide mentorship during on-the-floor manufacturing
- Support audits, inspections, and investigations
- Perform quarantine, segregation of material, and line clearances
- Contribute to continuous improvement initiatives
- Adjust schedule based on facility start up, filling, and manufacturing needs
- Collaborate with cross-functional internal teams

Qualifications:
- Requires B.S. in life sciences or related field and 6+ years of experience (may substitute proven experience for education)

Benefits (if part of job description):
- Student loan paydown program & tuition reimbursement; Family Care Benefits; Relocation assistance; Inclusion/culture and well-being programs (physical & mental health)

Application Instructions:
- Apply now.