Quality Assurance Associate - 1st ShiftAlliance Medical Products • Irvine, California, United States

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Quality Assurance Associate - 1st Shift

Alliance Medical Products

Irvine, California, United States

Irvine, California, United States

À propos

Job Overview 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 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 weekend 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 401K Company Background Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know‑how and experience makes us the most trusted partner in the pharmaceutical industry.
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Irvine, California, United States

Compétences linguistiques

English

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