On-Site QA Specialist - 1st Shift

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

Job Details

Job Location: Scientific Protein Laboratories - Waunakee, WI 53597

JOB SUMMARY

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an On‑Site QA Specialist.

Under minimal supervision from senior team members, this position is responsible to execute written procedures associated with on‑site Quality Assurance responsibilities including but not limited to on‑site inspection, batch record review and raw material inspection/release.

Responsibilities

• The On‑Site QA Specialist will be introduced to the on‑site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the On‑Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.
• Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.
• Reviews executed batch records.
• Performs 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.
• Provides administrative support for the on‑site QA department such as generation of DCRs, file organization, data compilation, training activities, etc.

Job Requirements and Qualifications

Position will be filled up to the mid‑level and determined at discretion of the hiring manager.

• Education: Bachelor’s degree or above required; Bachelor’s degree or above in a Scientific discipline preferred.
• Experience: 2 plus years of experience required; 5 plus years of experience preferred.
• Schedule: 1st shift.

Perks

Competitive compensation; excellent benefits package – including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long‑term Disability; Health and Flexible Savings Accounts; Employee Assistance Program, generous vacation; paid Holidays; 401(k); advancement opportunities; team‑oriented environment; community involvement; company events and more!

Equal Employment Opportunity Statement

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.