Quality Assurance Associate - 1st ShiftBioSpace, Inc. • Irvine, California, United States
Quality Assurance Associate - 1st Shift
BioSpace, Inc.
- Irvine, California, United States
- Irvine, California, United States
Über
Your Role The Quality Associate supports the Quality Assurance Operation, which consists of QA shop floor supports and QA batch review and product release on the 1st Shift.
Shift: 6 AM – 2:30 PM (1st Shift)
Responsibilities QA Production Floor Support
Provide quality support to manufacturing personnel on the shop floor for compounding and QA‑in‑process checks.
Perform line clearance verification, sterilization chart review, scale calibration verification, and QA‑in‑process checks including but not limited to visual inspection, CSIT/PID test, weight check, and torque test.
Perform AQL and Level II visual inspection for finished products.
Prepare in‑process samples for submission to the Quality Control laboratory.
Support handling of GMP events and initiation of deviation investigations.
Read, understand, and follow SOPs and comply with cGMP and GDP. Support the issuance of GMP documentation to the manufacturing floor.
QA Batch Review and Product Release
Review executed batch records for completeness, accuracy and compliance with approved procedures and Good Documentation Practices (GDP) and resolve discrepancies with manufacturing operators or supervisors.
Use computerized systems and software such as SAP, LIMS, and TrackWise for data collection and batch record review.
Enter and verify data from executed batch records into the Product Log Sheet and maintain the database up to date at all times.
Participate in deviation investigation and CAPA implementation.
Initiate Certificate of Conformance and prepare executed batch records for product release in a timely manner to meet compliance requirements and business needs.
Scan and file batch records (physically & electronically).
Assist in writing and/or revising SOPs to ensure compliance with cGMP and other applicable regulations.
Required Knowledge, Skills and Abilities
Working knowledge of QA principles in pharmaceutical and/or other FDA‑regulated industries required.
Good computer skills.
Strong attention to detail.
Good oral and written communication skills.
Ability to work overtime and/or work occasionally on weekends as needed.
Required Education and Experience
BS degree in biochemistry, chemistry, engineering, biology or closely related discipline required.
2–3 years of experience in quality assurance/manufacturing environment in pharmaceutical or other GMP‑regulated industries required.
3+ years of experience performing batch record reviewing strongly preferred.
Target Pay Range $31–34/hour
Your Benefits
Medical, Dental, Vision
Flexible Spending & HSA Options
Life Insurance, Short & Long Term Disability
Pet Insurance
401(k)
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Sprachkenntnisse
- English
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