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

• 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.
• Update various information indices (Excel, Access, etc.) as necessary.
• Prepare logbooks and issue logbooks and notebooks for use across the site.
• Support Regulatory Affairs (US and Canada) by assisting in gathering information for submissions and annual reports.
• Ensure daily tasks are completed in a timely manner with strict attention to detail, and in accordance with applicable SOPs and cGMPs.
• Assist with audits (preparation, set-up, breakdown, retrieval of requested 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.).
• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.
• Ensure maintenance of the department, premises, and equipment.

• Associates degree preferred, High School Diploma or equivalent is required.
• 1 or more years of documentation experience in a cGMP facility or in the medical transcription field is required. Office administration experience will also be considered.
• 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 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.