Document Control Technician

Scientific Protein Laboratories • Waunakee, WI

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About The Position

Scientific Protein Laboratories (SPL), a biopharmaceutical company specializing in the development and cGMP-compliant manufacturing of Active Pharmaceutical Ingredients, is hiring a Document Control Technician at its Waunakee, Wisconsin location. The technician will process and maintain controlled documents and quality records, ensuring accuracy, completeness, and compliance with applicable regulatory requirements. The role supports traceability and accountability through the control and release of documents in accordance with corporate requirements and current Good Manufacturing Practices (cGMP). Job level and compensation will depend on the selected candidate’s education, experience, skills, and overall qualifications.

Requirements

• High school diploma or GED.
• 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 ability to use Adobe Acrobat, Microsoft Word, and Excel.

Nice To Haves

• Associate degree or higher in a related discipline.

Responsibilities

• Stay current with FDA cGMP requirements regarding document control systems.
• Ensure appropriate issuance and retrieval of controlled documents.
• Ensure outdated or obsolete documents are returned or retrieved and that previously issued copies are accounted for and destroyed.
• Maintain relevant databases.
• Issue product batch and packaging records and assign lot numbers according to established procedures and production schedules.
• Assist in editing controlled documents for proper format and content in accordance with existing SOPs 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 appropriate facility locations.
• Maintain files on all controlled documentation.
• File, scan, and archive controlled documents.
• Issue and maintain documentation associated with shipments.

Benefits

• Competitive compensation
• Medical insurance
• Dental insurance
• Vision insurance
• Life and AD&D insurance
• Short- and long-term disability
• Health and Flexible Saving Account options
• Employee Assistance Program
• Generous vacation
• Paid holidays
• 401(k)
• Advancement opportunities
• Team-oriented environment
• Community involvement
• Company events

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED