QA Associate I (2nd Shift) — Product Release & QA Support

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

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.