Senior Quality Documentation Specialist

Process various site documents using computer based systems, including, but no 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, including, but no limited to, SOPs, Regulatory Documents and Validation Protocols. Update various information containing 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 Support Regulatory Affairs (US and Canada) by supplying current/historical documents and assist in gathering information for audit events. Reference summaries. Ensure daily tasks are completed in a timely manner with strict attention to detail, and in accordance to applicable SOP's, and cGMPs. Provide training on job specific Document Control processes for new employees and temporary/contract workers. Assist with audits (preparation, set-up, breakdown, and assist with the retrieval of requested documents).

Schedule: Monday - Friday 8am - 4:30pm

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.
• Ensure the maintenance of their department, premises and equipment.
• 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.).

• Associate degree preferred, High School Diploma or equivalent required. Work experience is considered in lieu of degree.
• 3 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 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.