7 дней назад
Quality Control Specialist (Pharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Specialist (Pharmaceutical): Leading in-process and post-production quality checks in a sterile compounding environment with an accent on compliance with USP and cGMP standards. Focus on managing investigations, equipment calibration, and ensuring regulatory adherence in a production facility.
Location: Must be based in New Albany, Ohio (On-site)
Company
is a leading health and wellness platform dedicated to making personalized healthcare accessible, affordable, and personal.
What you will do
- Lead in-process and post-production quality checks, including product inspection and testing.
- Manage daily production floor activities to ensure compliance with quality standards and raw material specifications.
- Oversee investigations into non-conformances, deviations, and customer complaints, driving root cause analysis.
- Maintain oversight of critical equipment verifications and calibrations.
- Draft, revise, and implement SOPs and protocols in alignment with USP and cGMP requirements.
- Train and mentor pharmacy and production staff on quality standards and procedures.
Requirements
- 3+ years of experience in quality control or quality assurance within a sterile compounding or pharmaceutical manufacturing environment.
- Must have experience working in a sterile floor environment.
- Strong working knowledge of USP <795, 797, and 800> and cGMP standards.
- Must have or be willing to obtain a Pharmacy Technician license within six months.
- Must be able to wear required PPE, including respiratory protection, and meet physical requirements for a 12-hour shift.
- Must be willing to confirm understanding of risks associated with handling Hazardous Drugs (HD).
Nice to have
- Experience in a 503A or 503B compounding facility.
- Prior management of environmental monitoring or contamination control programs.
- Experience supporting facility expansions or FDA inspections.
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).
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