Quality Assurance Associate I - 2nd Shift (Pharmaceutical)

Location: Irvine, California, United States; onsite, 2nd shift from 2:00 PM to 10:30 PM, Monday through Friday

Salary: $30–$32 per hour plus a 10% differential for 2nd Shift

Company

hirify.global is a pharmaceutical contract development and manufacturing organization that develops and manufactures APIs and finished dosage forms across a global network of sites.

What you will do

• Provide quality support to manufacturing personnel on the production floor, including compounding and QA in-process checks.
• Perform line clearance verification, sterilization chart review, scale calibration verification, visual inspections, CSIT/PID tests, weight checks, torque tests, and finished-product inspections.
• Prepare in-process samples for the Quality Control laboratory and support GMP events, deviation investigations, and CAPA implementation.
• Review executed batch records, resolve discrepancies, enter and verify data, and maintain product log sheets and databases.
• Initiate Certificates of Conformance and prepare batch records for product release.
• Support SOP writing and revision, GMP documentation issuance, and physical and electronic record filing.

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.
• Strong attention to detail, good computer skills, and effective oral and written communication.
• Ability to work overtime and weekends as needed.
• Experience or ability to work with SAP, LIMS, and TrackWise for data collection and batch record review.

Culture & Benefits

• Medical, dental, vision, and life insurance.
• Voluntary accident, hospital, and pet insurance.
• 401(k) plan.
• PTO, holidays, sick leave, and personal time.
• Collaborative environment focused on safety, quality, sustainability, and professional growth.