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 Structure

Job summary

Siegfried is seeking a QA Associate I for the 2nd Shift (2 PM - 10:30 PM) in Irvine, CA. You will support QA Production Floor activities, perform in-process checks, and review batch records to ensure GDP and GMP compliance, using SAP, LIMS, and TrackWise to document data.

Qualified candidates have a Bachelor’s in a related science and 1–2 years in QA/manufacturing within GMP environments, with flexibility for overtime and weekend work.

Qualifications

• Working knowledge of QA principles in FDA-regulated industries.
• Good computer skills.
• Strong attention to detail.
• Good oral and written communication skills.
• Ability to work overtime and/or weekends as needed.

Responsibilities

• Provide QA on the Production Floor for compounding and in-process checks.
• Review batch records for accuracy and GDP/GMP compliance.
• Use SAP, LIMS, TrackWise for data collection and batch review.
• Participate in deviation investigations and CAPA implementation.
• Initiate Certificate of Conformance and prepare batch records for product release.
• Read/write SOPs and ensure cGMP compliance.

Skills

QA principles

Computer skills

Attention to detail

Communication skills

Overtime/weekend flexibility

Education

Bachelor's Degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline

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.