Document Control Technician

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 Document Control Technician.

As part of the document control team, you will process and maintain controlled documents and quality records while ensuring accuracy, completeness, and compliance with applicable regulatory requirements. You will be key to providing traceability and accountability through control and release of documents as required by corporate and current Good Manufacturing Practices (cGMP).

Responsibilities include:

• Keep current with FDA cGMP requirements regarding document control systems.
• Assure appropriate issuance and retrieval of controlled documents. Assure return or retrieve outdated or obsolete documents; assure all previously issued copies are accounted for and destroyed. Maintain relevant databases
• Issue product batch/packaging records and properly assign lot numbers based on established procedures and production schedules
• Assist in editing controlled documents for proper format and content per existing Standard Operating Procedures (SOP) and cGMP guidelines
• Assign and route controlled documents in accordance with document control SOPs. Assign effective dates and copy and place new or revised SOPs in proper locations throughout the facility
• Maintain files on all controlled documentation. File, scan and archive controlled documents
• Issue and maintain all documentation associated with shipments

Job Requirements and Qualifications:

This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate’s education, experience, skills, and overall qualifications.

Education:

High School Diploma or G.E.D., associate degree or above in related discipline preferred

Experience:

• Experience with business-related systems
• Experience managing multiple priorities
• Experience managing competing deadlines with satisfactory results
• Experience communicating with customers regarding their needs and wants
• Competent knowledge of, and the ability to use, Adobe Acrobat, Microsoft Word, and Excel

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.