2nd Shift QA Associate - GMP Compliance & Release

Initial Therapeutics, Inc.; Irvine (CA); On-site; USD 41,328 - 44,083; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Voluntary Benefits

401K

Paid Time Off

Job summary

Siegfried is seeking a QA Associate I to support Quality Assurance operations on the 2nd shift (2 PM–10:30 PM, Mon–Fri). The role covers QA Production Floor support, in-process checks, and product release activities to ensure cgMP compliance.

Candidates should have a Bachelor’s degree in a scientific field and 1–2 years of QA or GMP exposure. Responsibilities include batch record review, deviation handling, and data entry using SAP/LIMS/TrackWise, with an emphasis on accuracy and regulatory

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required
• 1–2 years' experience in Quality Assurance / Manufacturing in Pharma or GMP environment preferred
• Knowledge of cGMP and GDP principles desirable

Responsibilities

• Support QA on the 2nd shift on the production floor and QA batch review
• Review batch records for completeness and compliance with GDP and approved procedures
• Use SAP, LIMS, TrackWise for data collection and batch record review
• Prepare in-process samples for QC lab and initiate deviation investigations
• Assist with SOPs revision to ensure cGMP compliance

Skills

QA principles

Attention to detail

Communication skills

Overtime availability

Good computer skills

Education

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

Tools

SAP

LIMS

TrackWise

Job description

Siegfried is seeking a QA Associate I to support Quality Assurance operations on the 2nd shift (2 PM–10:30 PM, Mon–Fri). The role covers QA Production Floor support, in-process checks, and product release activities to ensure cgMP compliance.

Candidates should have a Bachelor’s degree in a scientific field and 1–2 years of QA or GMP exposure. Responsibilities include batch record review, deviation handling, and data entry using SAP/LIMS/TrackWise, with an emphasis on accuracy and regulatory