6 дней назад
QA Associate (Pharmaceutical Manufacturing)
68 600 - 114 300$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QA Associate (Pharmaceutical Manufacturing): Reviewing and approving GMP batch records, investigations, SOP revisions, and validation documentation for pharmaceutical manufacturing with an accent on compliance, batch release accuracy, and inspection readiness. Focus on resolving quality issues, supporting real-time manufacturing compliance, and driving corrective actions and continuous improvement.
Location: On-premise in Andover, Massachusetts, United States. Candidates must have permanent authorization to work in the United States; U.S. work visa sponsorship is not available.
Annual base salary: $68,600–$114,300, plus eligibility for a 7.5% bonus target.
Company
develops and manufactures pharmaceutical products focused on delivering safe and effective treatments to patients.
What you will do
- Review and approve GMP records, primarily drug substance and drug product batch records, investigations, SOP revisions, and validation documentation.
- Ensure batch-release documentation is complete and accurate.
- Make quality decisions on moderately complex issues and escalate matters beyond the role’s authority.
- Assess compliance with applicable regulations and support ongoing inspection readiness and audits.
- Support manufacturing staff in detecting and resolving compliance errors in real time.
- Define improvement action plans, follow up on closures, and participate in continuous improvement and corrective action effectiveness activities.
Requirements
- Bachelor’s degree with any years of experience, or an associate’s degree with 4 years of relevant experience, or a high school diploma with 6 years of relevant experience.
- Experience in the pharmaceutical industry and sound knowledge of current GMP and applicable GxP regulations and standards.
- Ability to work independently and in cross-functional teams, with strong critical-thinking, communication, and interpersonal skills.
- Experience with digital applications and solutions such as Co-Pilot, AI applications, or electronic batch records.
- Permanent U.S. work authorization is required; visa sponsorship is unavailable now and in the future.
- Ability to work on site, including walking, standing, sitting, and carrying batch records across the campus.
Nice to have
- Experience at a manufacturing site.
- Experience writing and managing deviations.
- Experience with production batch record review, ERP systems, non-conformance investigations, root cause analysis, and change control management.
Culture & Benefits
- Quality-focused, science-driven, and risk-based compliance culture.
- Participation in ’s Global Performance Plan with a 7.5% bonus target.
- 401(k) with matching and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
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