Supervisor Document Control

The Document Control Supervisor is responsible for the oversight, coordination, and execution of the site's Document Management systems. The position is responsible for document processing, issuance, maintenance, and archival of various documents/records and maintenance associated indices. The position is also responsible for troubleshooting and resolution of document processing and formatting issues. The Document Control Supervisor is responsible for leading and managing the Document Control team and associated personnel as needed. The position is responsible for ensuring compliance to applicable internal procedures, cGMPs, and regulatory requirements.

Schedule: Monday - Friday 7:00 am - 4:00 pm

• Responsible for Document Management at the site, including compliance of Document Management System(s) to the applicable regulations.
• Responsible for ensuring adherence to site procedures and applicable regulations for the lifecycle of documents, including the routing, review, approval, distribution, and archival of new and revised controlled documents.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Establish and maintain the records management system including secure storage, retrieval, retention, and destruction.
• Manage the Document Control team in daily tasks and development, including coordination and dissemination of daily assignments to the team.
• Process various site documents using computer-based systems, including, but not limited to: Standard Operation Procedures (SOPs), Standard Testing Methods (STMs), Specifications, and Batch Production Records.
• Catalog, scan, maintain, archive/file and retrieve various site documents/records, including, but not limited to, SOPs, Batch Records, Datasheets, Logbooks, Notebooks, Regulatory Documents, and Validation Protocols.
• Troubleshoot anomalies and formatting issues in Microsoft programs.
• Collaborate and coordinate with other functions (e.g., Document Owners, Quality Systems Administrators, and Training), as necessary, in the processing of documents.
• Assure controlled documents are periodically reviewed for relevance and accuracy and that actual practices are reflected as defined in applicable procedures.
• Assemble, analyze, and report metrics on the state of Quality-controlled documents to ensure regulatory compliance, and identify trends and areas of improvement.
• Investigate and drive for resolution of department Exceptions, Corrective Actions, and/or safety issues.
• Provide guidance and coaching to site personnel through quality decisions that support the Quality Department initiatives.
• Develop and execute continuous improvement efforts, according to project plans and timelines, for projects identified in the Quality organization.
• Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and standard operating procedures.
• Additional areas of responsibility may include developing standard operating procedures, providing quality system training, and assisting in the preparation of regulatory submissions.

• Bachelor Degree preferred. Work experience is considered in lieu of degree.
• Ten or more years of relevant work experience required.
• Two years of experience leading a team including hiring, coaching, and development of technicians and/or professionals.
• Must have expert experience with computer data entry.
• Must be proficient with Microsoft Office, including Word, Excel, Access, Visio, Outlook, and PowerPoint and must be able to troubleshoot these applications.
• Must possess strong grammatical and document layout/design/formatting skills.
• Must have experience in a pharmaceutical environment with strong understanding of and exposure to Quality Systems, especially Document Management and Change systems.
• Must have a working knowledge of regulatory requirements and cGMP guidelines and their application in a pharmaceutical facility.
• Must have experience with statistical tools and Quality Management Systems applications.
• Must have experience in supporting on-site inspections of regulatory agencies.
• Must possess strong problem solving and decision-making skills and be able to assess risk and impact in relation to decisions.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Must be thorough and detail oriented.
• Must possess effective verbal and written communication, organization, and time management skills.
• Must be results-oriented and able to adapt quickly, make decisions, and prioritize work per business needs in a fast-paced environment.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.