On-Site QA Specialist

Scientific Protein Laboratories LLC; 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

Job Details: Job Location: Scientific Protein Laboratories - Waunakee, WI, Salary Range: Undisclosed, 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. Schedule is Monday-Friday, 8am-4:30pm, with some flexibility.

Responsibilities include:

• 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.

Job Requirements and Qualifications:

Education:

• 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

Experience:

• 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
• 2 years’ conducting walk throughs using checklists
• Completing Control Document revisions
• Conducting Inspections
• Experience ensuring operators are adhering to safety procedures and company policies

WHY JOIN SPL?

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

• 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 Saving Account options
• Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more

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.