On-Site QA Specialist: Drive Batch Records & Compliance

Scientific Protein Laboratories; Waunakee (WI); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

Health Savings Accounts

Job summary

Scientific Protein Laboratories (SPL) in Waunakee, WI is seeking an On-Site QA Specialist to join our biosourced pharmaceutical manufacturing team. This role performs QA duties with minimal supervision, focusing on on-site inspection, batch record review, and raw material release in a cGMP environment.

The candidate will learn to independently provide QA support, with responsibilities including deviations, investigations, CAPAs, and shipping release procedures.

Qualifications

• Bachelor’s degree or above in a scientific discipline.
• 2+ years of experience required; 5+ years preferred.
• 1st shift schedule.

Responsibilities

• Support on-site QA department and perform QA duties under supervision.
• Review batch records and evaluate material documentation.
• Inspect and disposition raw materials per specifications.
• Write deviations, investigations, change controls and CAPAs.
• Assist in shipping release procedures and Annual Product Review preparation.
• Provide administrative support to the on-site QA team.

Skills

cGMP experience

QA documentation

batch records review

deviations & CAPAs

Education

Bachelor's degree in a scientific discipline

Job description

Scientific Protein Laboratories (SPL) in Waunakee, WI is seeking an On-Site QA Specialist to join our biosourced pharmaceutical manufacturing team. This role performs QA duties with minimal supervision, focusing on on-site inspection, batch record review, and raw material release in a cGMP environment.

The candidate will learn to independently provide QA support, with responsibilities including deviations, investigations, CAPAs, and shipping release procedures.