(Contractor) Quality Documentation Specialist

The Quality Documentation Specialist position is responsible for coordination and management of the administration and execution of the Document Control systems. The position is responsible for document processing, maintenance of documents/records, issuance of logbooks, notebooks and protocols, and maintenance of various indices/logs. The position is responsible for ensuring compliance to applicable internal procedures, cGMPs, and regulatory requirements.

Work Schedule: Monday - Friday 8:00 am - 5:00 pm

• Execution and dissemination of daily assignments from the Document Control Team.
• Process various site documents using computer-based systems, including, but not limited to, Standard Operation Procedures (SOPs), Standard Certification Methods (SCMs), 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.
• Prepare and issue logbooks and notebooks for use across the site.
• Collaboration and coordination with other functions (e.g. Document Owners, Quality Systems Administrators, and Training), as necessary, in the processing of documents.
• Support Regulatory Affairs (US and Canada) by supplying current/historical documents and assist in gathering information for audit events.
• Ensure daily tasks are completed in a timely manner with strict attention to detail, and in accordance with applicable Standard Operating Procedures and cGMPs.
• 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.).
• Lead training efforts for Document Control processes for new personnel to the department.
• Provide support (preparation, set-up, breakdown, and assist with the retrieval of requested documents) for FDA or other regulatory inspections and customer audits.
• Troubleshoot anomalies and formatting issues in Microsoft programs.
• Assist in Exception investigations, including root cause analysis and resolution with effective and timely corrective action.
• Perform document cross-reference searches using advanced search parameters.
• Ensure maintenance of the department, premises, and equipment.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.

• Associate degree preferred, High School Diploma or equivalent required. Work experience is considered in lieu of degree.
• 2 or more years of relevant work experience required.
• Experience with computer data entry required. Must be proficient with Microsoft Office, including Word, Excel, Access, Visio, Outlook, and Power Point.
• Willing to work occasional overtime and weekends as the business need dictates.
• Ability to work well both independently and in a team atmosphere.
• Demonstrated ability to closely adhere to all instructions, cGMP's, SOP's, policies and procedures required.
• Ability to accurately type 45 words per minute.
• Strong grammatical and document layout/design/formatting skills are mandatory.
• Strong organization skills are essential.
• Good communication skills.
• Strong organization and time management skills.

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 outside of regular work hours, including off shift, weekend, and holiday work as business needs require.