Documentation Systems Specialist 3

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

• Serving clients in 18 Countries
• Successful NDA and ANDA drug registrations
• In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Afton Scientific is seeking an experienced, detail-oriented Documentation Systems Specialist III to join our Quality Assurance team. This position plays an important role in maintaining the integrity, accuracy, and control of Afton's documentation systems while supporting our pharmaceutical manufacturing and quality operations.

The Documentation Systems Specialist III is responsible for the administration and control of master documents and associated databases. This is an excellent opportunity for an individual with strong documentation skills, cGMP knowledge, and experience working within a regulated pharmaceutical or biopharmaceutical environment.

Compensation

$25.00 – $35.00 per hour

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

Primary Responsibilities

·         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.

Minimum Qualifications

·         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.

Preferred Knowledge and Experience

·         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.

Key Competencies

·         Attention to Detail & Accuracy

·         Documentation & Data Integrity

·         Quality & Regulatory Compliance

·         Organization & Prioritization

·         Communication & Collaboration

·         Accountability & Follow-Through

·         Independent Problem Solving

·         Customer & Stakeholder Support

What You'll Gain

·         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.

Physical & Work Requirements

·         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.