Quality Assurance Associate - 1st Shift

Siegfried•Irvine, CA

2d•$31 - $34

About The Position

Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. 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. 1st Shift Hours: 6 AM - 2:30 PM Your Profile: 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 SOP’s 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.

Requirements

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 weekend as needed
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

Nice To Haves

3+ years of experience performing Batch Record Reviewing strongly preferred

Responsibilities

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 SOP’s and comply with cGMP and GDP.
Support the issuance of GMP documentation to the Manufacturing floor.
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.