Quality Specialist (Pharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Quality Specialist (Pharmaceutical): Supporting quality operations at a peptide-focused API manufacturing site with an accent on GMP compliance, document control, and quality systems management. Focus on building an inspection-ready foundation, managing deviations and CAPAs, and ensuring rigorous adherence to Good Documentation Practices in a startup-driven development environment.
Location: On-site in Menlo Park, California.
Salary: $95,000 – $115,000 (for US-based candidates).
Company
is a leading health and wellness platform dedicated to making personalized healthcare affordable, accessible, and personal.
What you will do
- Support day-to-day site Quality Systems including document control, training, deviations, CAPA, and change control.
- Review GMP records for completeness, accuracy, and compliance with approved procedures.
- Assist with issuance, tracking, and archival of controlled documents like SOPs, forms, and protocols.
- Support batch record review for peptide API manufacturing and escalate issues to leadership.
- Participate in routine walkthroughs of manufacturing and laboratory areas to reinforce compliance.
- Support inspection readiness activities, including document retrieval and internal/external audit participation.
Requirements
- Bachelor’s degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related field.
- 2–5+ years of experience in Quality, manufacturing, or document control within GMP-regulated environments.
- Working knowledge of cGMP principles and Good Documentation Practices.
- Strong organizational skills with the ability to manage multiple priorities.
- Experience using electronic quality, document management, or training systems.
- Must be able to work on-site in Menlo Park, California.
Nice to have
- Experience with peptide API or sterile operations.
- Background in startup or early-phase drug product development environments.
Culture & Benefits
- Competitive salary and equity compensation.
- Unlimited PTO, company holidays, and quarterly mental health days.
- Comprehensive health benefits including medical, dental, vision, and parental leave.
- 401k benefits with employer matching.
- Employee Stock Purchase Program (ESPP).
- Offsite team retreats and a talent-first flexible culture.
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