7 часов назад
Quality Assurance Associate I - 2nd Shift (Pharmaceutical)
30 - 32$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Quality Assurance Associate I - 2nd Shift (Pharmaceutical) (GMP/QA): Supporting pharmaceutical manufacturing quality operations through production-floor checks, batch record review, and finished-product release with an accent on cGMP compliance, documentation accuracy, and in-process inspection. Focus on investigating deviations, implementing CAPA, reviewing electronic quality data in SAP, LIMS, and TrackWise, and preparing records for compliant product release.
Location: Irvine, California, United States; onsite, 2nd shift from 2:00 PM to 10:30 PM, Monday through Friday, with overtime and weekend work as needed.
Target pay: $30–$32 per hour, plus a 10% second-shift differential.
Company
is a global pharmaceutical CDMO that develops and manufactures APIs and finished dosage forms across 16 sites on three continents.
What you will do
- Provide quality support to manufacturing personnel during compounding and in-process checks on the production floor.
- Perform line clearance verification, sterilization chart review, scale calibration verification, visual inspections, CSIT/PID tests, weight checks, torque tests, and AQL inspections.
- Prepare in-process samples for Quality Control laboratory submission and support GMP event handling and deviation investigations.
- Review executed batch records, resolve discrepancies, enter and verify product data, and maintain product log databases.
- Initiate Certificates of Conformance and prepare, scan, and file batch records for timely product release.
- Participate in CAPA implementation and assist with writing or revising SOPs.
Requirements
- Bachelor’s degree in Biochemistry, Chemistry, Engineering, Biology, or a closely related discipline.
- 1–2 years of experience in Quality Assurance or a manufacturing environment within pharmaceutical or other GMP-regulated industries.
- Working knowledge of QA principles in pharmaceutical or other FDA-regulated industries.
- Good computer, oral communication, written communication, and attention-to-detail skills.
- Ability to work the specified second shift and additional overtime or weekend hours as needed.
Culture & Benefits
- Collaborative environment with opportunities for personal and professional growth.
- Medical, dental, vision, and life insurance.
- Voluntary accident, hospital, and pet insurance options.
- 401(k) plan.
- PTO, holidays, sick leave, and personal time off.
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