Quality Systems QA Specialist

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 a Quality Systems QA Specialist.

Under minimal supervision of senior team members, this position is responsible to execute written procedures associated with Quality System QA responsibilities including but not limited to cGMP training, review of validation/qualification documents, investigations (including customer complaints), deviations, change controls and CAPAs.

Responsibilities include:

• The Quality Systems QA Specialist will be introduced to the Quality System 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 Quality Systems QA Specialist will quickly learn to independently provide quality system support to the organization as outlined below.
• Manage SPL’s training program, including GMP training and training documentation.
• Reviews and approves validation/qualification documents.
• Assists in facilitating and reviewing the investigation of process deviations, product failures, customer complaints or facility incidents and assures proper documentation and investigation per established procedures.
• Reviews and evaluates SPL compliance with Quality System QA procedures.
• Assist in administration of the Electronic Quality Management System (EQMS).
• Assists with tracking and trending of metrics for the Quality Systems QA Department.
• Assists and coordinates the preparation of the APR's for all SPL marketed product.
• Lead the Change Control committee meetings, including Change Control status and follow through on timeliness.
• Participates in audits and addresses audit findings where necessary.

Job Requirements and Qualifications:

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

• Associate

Education: Associate’s degree required; Bachelor’s degree or above in scientific discipline preferred

Experience: None required; 2 plus years preferred

• Specialist:

Education: Bachelor’s degree or above required; Bachelor’s degree or above in scientific discipline with experience with quality system processes and/or electronic quality management systems preferred

Experience: 2 plus years required; 5 plus years preferred

WHY JOIN SPL?

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

Perks include: 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.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Work Location: In person