Records Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This is a fully-onsite role based at our GMP Laboratory in Middleton, WI . We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Location: Middleton, WI Available Shifts: Full-Time; 1st Shift, Monday - Friday, 8PM - 4PM CT The Records Specialist is responsible for providing records management and document control support for GMP laboratory operations. Working closely with Quality Assurance, laboratory personnel, and cross-functional teams, this role ensures that GMP records are accurately processed, maintained, archived, and retrieved in accordance with company procedures, regulatory requirements, and Good Manufacturing Practice (GMP) standards. The Records Specialist plays a critical role in supporting compliant laboratory operations by ensuring the integrity, accessibility, and lifecycle management of controlled records.

Process, review, index, file, archive, and retrieve GMP laboratory records in accordance with established procedures and records retention requirements. Support laboratory personnel by fulfilling requests for controlled records and archived documentation in a timely manner. Maintain physical and electronic records management systems to ensure accurate record organization, traceability, and accessibility. Perform quality reviews of records to verify completeness, accuracy, and compliance with GMP documentation practices. Collaborate with laboratory and Quality teams to resolve documentation discrepancies and ensure timely completion of records. Support document archival, retention, and disposition activities in accordance with company policies and regulatory requirements. Assist with inspection readiness by locating, organizing, and providing records for internal audits and regulatory inspections. Maintain inventory and organization of archived records and storage areas. Provide guidance to laboratory personnel on records management processes and documentation best practices. Participate in continuous improvement initiatives and support special projects related to records management and document control.

Operates Records Management and Document Control Systems Logs, stores, retrieves and monitors circulation of laboratory records including analytical methods and protocols and general laboratory physical records. Provides general records management (GRM) and file room support by working closely with project teams to ensure all records management tasks are completed according to organization and/or client standard operating procedures (SOP) and FDA good laboratory practices and/or good manufacturing practices including maintain security of the archives.

Requirements: High school diploma or equivalent required; Associate's degree preferred. Minimum of two years of experience in records management, document control, laboratory support, or a related GMP-regulated environment preferred. Equivalent combinations of education, training, and directly related experience will be considered. Knowledge, Skills, & Abilities: Working knowledge of Good Manufacturing Practices (GMP) and documentation standards preferred. Strong organizational skills with exceptional attention to detail and accuracy. Ability to manage multiple priorities while meeting established deadlines. Experience working with electronic document management and records management systems. Strong computer proficiency, including Microsoft Office applications. Effective written and verbal communication skills with the ability to collaborate across functional teams. Ability to identify documentation issues and