Quality Assurance Associate I - 2nd Shift

BioSpace; Irvine (CA); On-site; USD 41,000 - 44,000; Full time

Benefits offered by this job

Medical Dental Vision Life

Voluntary Accident Hospital Pet

401K

Generous Time Off

Job summary

Siegfried is seeking a QA Associate I to support QA operations on the 2nd Shift, focusing on QA Production Floor support and QA Product Release. Schedule: 2 PM - 10:30 PM, Monday through Friday, with potential overtime.

Responsibilities include line clearance, visual inspection, and batch record review to ensure cGMP compliance. Qualifications include a Bachelor's in a related field and 1–2 years in QA/manufacturing within GMP-regulated environments.

Qualifications

• QA principles in pharmaceutical or FDA-regulated environments.
• Proficient computer skills.
• Strong attention to detail and accuracy.
• Strong written and verbal communication skills.
• Willingness to work overtime/weekends as needed.

Responsibilities

• Support QA Production Floor and QA Product Release on 2nd Shift.
• Perform line clearance, chart review, calibration verification, and in-process QA checks.
• Perform AQL and Level II visual inspections for finished products.
• Prepare samples for QC testing and support GMP deviation investigations.
• Review batch records for compliance and integrity; resolve discrepancies.
• Utilize SAP, LIMS, and TrackWise for data collection and batch review.
• Initiate Certificates of Conformance and prepare records for release.

Skills

QA principles

Good computer skills

Attention to detail

Communication skills

Overtime/weekend availability

Education

Bachelor's Degree in Biochemistry/Chemistry/Engineering/Biology

1-2 years QA/Manufacturing GMP experience

Tools

SAP

LIMS

TrackWise

Job description

"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 QA Associate I supports the Quality Assurance Operation on the 2nd Shift, which consists of QA Production Floor supports, and QA Product Release.

2nd Shift Hours: 2 PM - 10:30 PM Monday through Friday

Responsibilities

Your Profile:

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.

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 on weekend as needed

Required Education And Experience

• Bachelor's Degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required
• 1-2 years' experience in Quality Assurance / Manufacturing environment in Pharmaceutical or other GMP regulated industries required

Target Pay Range: $30-32/hour +10% Differential when working on 2nd Shift (2 PM -10:30 PM)

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.

Your Benefits

• Medical, Dental, Vision, Life
• Voluntary Accident, Hospital, Pet
• 401K
• Generous Time Off Structure including PTO, Holidays, Sick & Personal

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 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.