On-site QA Specialist: cGMP Manufacturing & Batch Review

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 Account

Employee Assistance Program

401(k) plan

Paid Holidays

Generous vacation

Career advancement opportunities

Job summary

Scientific Protein Laboratories (SPL) seeks an Operations On-site QA Specialist in Waunakee, WI. This role performs on-site QA tasks under supervision, learns to independently support QA functions, and participates in batch record reviews, documentation verifications, and audits to ensure cGMP compliance at our Waunakee site.

Qualifications include a science degree or 2+ years QA in regulated industry, with 2+ years writing deviations/investigations and conducting inspections; prior cGMP pharma

Qualifications

• Bachelor’s Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry
• 2 years’ experience writing deviations and investigations
• 2 years’ conducting walk throughs using checklists
• Completing Control Document revisions
• Conducting Inspections
• Experience in cGMP in a pharma manufacturing facility

Responsibilities

• Conducts on-the-floor reviews of manufacturing and testing operations
• Performs verifications to support batch records, cleaning records, logbooks and test methods
• Assists in identification and evaluation of facility events
• Performs on-the-floor reviews of executed batch records
• Assists in establishing/maintaining procedures and documents
• Supports the document control team in issuing records as needed

Education

Bachelor’s Degree in a Scientific discipline

2+ years QA experience in a regulated industry

2 years’ experience writing deviations and investigations

2 years’ conducting walk throughs using checklists

Conducting Inspections

Experience ensuring operators adhere to safety procedures

Job description

Scientific Protein Laboratories (SPL) seeks an Operations On-site QA Specialist in Waunakee, WI. This role performs on-site QA tasks under supervision, learns to independently support QA functions, and participates in batch record reviews, documentation verifications, and audits to ensure cGMP compliance at our Waunakee site.

Qualifications include a science degree or 2+ years QA in regulated industry, with 2+ years writing deviations/investigations and conducting inspections; prior cGMP pharma