Principal Associate I, Plant Quality Assurance - 2ND SHIFT
$120,000–$155,000 year
On-siteFramingham, Massachusetts, United States
Job Summary
Lead the second shift QA team to ensure real-time quality oversight for Drug Substance and Drug Product activities, maintaining strict compliance with cGMP and GDP standards. Conduct floor walkthroughs and inspections to sustain inspection readiness, while reviewing and approving executed batch records, logbooks, and QC assays. Drive closure of deviations, investigations, CAPAs, and change control records, and author or approve quality documents including SOPs, risk assessments, and validation protocols. Provide training on procedures, safety, and cGMP topics, and support internal and external audits as needed. Assist with continuous improvement initiatives for the Quality System. This 2nd shift role is based onsite in Framingham on a 4-day, 10-hour schedule.
Required Qualifications
- BA or BS in a Science or related field or equivalent experience in the Quality function
- 5-7+ years of experience in the pharmaceutical field including 5 years of years of Quality or Manufacturing experience
- Experience in managing multiple, competing priorities in a fast-paced environment
- Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations)
- Previous Quality Assurance oversight experience
- 2nd shift opportunity based on-site in our Framingham location
- 4-day (Mon – Thurs) 10-hour shift schedule
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