Document Control Technician

Scientific Protein Laboratories; Waunakee (WI); On-site; USD 42,000 - 70,000; Full time

Benefits offered by this job

Medical, Dental and Vision on Day 1

401k

Paid Holidays

Flexible Spending Account

Job summary

Scientific Protein Laboratories LLC in Waunakee, WI is seeking a Document Control Technician to maintain controlled documents and quality records in a cGMP environment. You will ensure accuracy, traceability, and regulatory compliance across the document lifecycle.

Responsibilities include issuing and retrieving documents, maintaining databases, and routing SOPs. Suitable candidates have a High School Diploma or GED with relevant experience; an associate degree or higher is preferred, and

Qualifications

• High school diploma or GED required; associate degree or higher preferred.
• Experience with business-related systems and managing multiple priorities.
• Ability to communicate with customers and meet deadlines.

Responsibilities

• Keep current with FDA cGMP requirements regarding document control systems.
• Assure issuance and retrieval of controlled documents; maintain databases.
• Issue product batch/packaging records and assign lot numbers per SOPs and schedules.
• Edit controlled documents for format/content per SOPs and cGMP guidelines.
• Route controlled documents per document control SOPs; place updated SOPs in appropriate locations.
• Maintain and archive all controlled documentation and shipments-related paperwork.

Skills

Multitasking

Customer communication

Regulatory compliance awareness

Education

High School Diploma or GED

Associate degree or above in related discipline

Tools

Adobe Acrobat

Microsoft Word

Excel

Job description

Job Details: Job Location: Scientific Protein Laboratories - Waunakee, WI 53597, 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. 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.