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7 часов назад

Quality Assurance Associate I - 2nd Shift (Pharmaceutical)

30 - 32$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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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

hirify.global 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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