Documentation Systems Specialist III

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

·         Support the overall administration and management of Afton's Documentation Systems.

·         Maintain master lists and approved controlled documents, including SOPs, directives, policies, batch records, protocols, and specifications.

·         Notify clients and appropriate stakeholders of changes to controlled documents.

·         Maintain records of approved change requests and investigation documentation.

·         Assign lot numbers and issue batch records.

·         Issue validation protocols for execution and process completed protocols following closure.

·         Write, review, and edit master documents, including SOPs, batch records, and specifications.

·         Review and approve Operational Deviation Reports (ODRs) and Change Control documentation, as applicable.

·         Support audits and pharmaceutical VIP visits by facilitating documentation requests.

·         Provide general administrative support as assigned.

·         Provide inspection support to Finishing Operations, as qualified.

·         Maintain positive and professional working relationships with coworkers, internal customers, and vendors.

·         Bachelor's degree or a minimum of five years of experience in pharmaceutical administration, documentation, or a related role.

·         General experience within biopharmaceutical production or Quality Control.

·         Comprehensive knowledge of cGMP requirements and applicable FDA and EU guidance related to aseptic processing.

·         Experience using a GMP-compliant document management system, such as MasterControl, Veeva, or a comparable platform.

·         Advanced computer skills, including Microsoft Word and Excel, with the ability to learn additional database applications.

·         Strong written and verbal communication skills.

·         Ability to maintain accurate records and manage documentation with a high degree of attention to detail.

·         Ability to work effectively with minimal supervision.

·         Ability to stand for extended periods as necessary.

·         Ability to lift up to 50 pounds and bend and reach as required.

·         Near vision correctable to 20/20, including through corrective eyewear when necessary.

·         Regular on-site attendance is required.

·         Experience administering controlled documentation within a pharmaceutical or biopharmaceutical environment.

·         Experience with MasterControl, Veeva, or another electronic document management system.

·         Experience working with SOPs, batch records, specifications, protocols, and other GMP-controlled documents.

·         Familiarity with Change Control and Operational Deviation processes.

·         Experience supporting internal, client, or regulatory audits.

·         Experience working cross-functionally with Quality Assurance, Quality Control, Operations, and other departments.

·         Attention to Detail & Accuracy

·         Documentation & Data Integrity

·         Quality & Regulatory Compliance

·         Organization & Prioritization

·         Communication & Collaboration

·         Accountability & Follow-Through

·         Independent Problem Solving

·         Customer & Stakeholder Support

·         Increased exposure to Afton's Quality Management System and controlled-document processes.

·         Experience supporting documentation critical to pharmaceutical manufacturing, validation, and Quality Assurance.

·         Opportunities to work across departments and support audits, investigations, change controls, and validation activities.

·         Continued development of expertise in cGMP documentation and electronic document management systems.

·         Opportunities for continued professional development and career growth within Afton Scientific.