On-Site QA Specialist — Elevate cGMP in Pharma

Paycom; Waunakee (WI); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental and Vision on Day 1

Life Insurance

Short/Long-term Disability

401k

Paid Holidays

Professional development

Job summary

Scientific Protein Laboratories (SPL) is hiring an On-Site QA Specialist in Waunakee, WI. The role supports quality systems, document control, and batch review in a regulated manufacturing setting.

Responsibilities include deviation writing, investigations, CAPAs, inspections, and admin support for the QA department. A science degree or 2+ years QA in a regulated industry is required. Monday–Friday schedule with some flexibility.

Qualifications

• Required: Bachelor’s Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry
• Preferred: Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industry
• Demonstrate a deep understanding of Quality and Quality systems
• Experience in cGMP in a pharma manufacturing facility
• 2 years’ experience in writing deviations and investigations

Responsibilities

• Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.
• Reviews executed batch records.
• Perform inspection and disposition of raw materials on the basis of approved specifications.
• Writes deviations, investigations, change controls and/or CAPAs.
• Performs shipping release procedures.
• Assists in the preparation of Annual Product Review documentation for all SPL Marketed Products.
• Administrative support for the on-site QA department such as generation of DCR's, file organization, data compilation, training activities, etc.

Skills

Quality Systems

cGMP

Documentation

Deviations

Investigations

Inspections

CAPA

Education

Bachelor's degree in scientific discipline

Tools

Checklists

Job description

Scientific Protein Laboratories (SPL) is hiring an On-Site QA Specialist in Waunakee, WI. The role supports quality systems, document control, and batch review in a regulated manufacturing setting.

Responsibilities include deviation writing, investigations, CAPAs, inspections, and admin support for the QA department. A science degree or 2+ years QA in a regulated industry is required. Monday–Friday schedule with some flexibility.