Document Control Associate

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Job description

Overview:
Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We're investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you're curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Document Control Associate at Cook Myosite maintains and manages the document management system. This role ensures quality and compliance for document control procedures and regulations in a cGMP environment.

Responsibilities:
• Support all activities related to Document Control in GMP Manufacturing

• Maintain the document control and change management system including the electronic data management system (EDMS)

• Serve as a document control subject matter expert and document administrator for the EDMS

• Oversee the daily operations of the Document Control process through MasterControl software. This includes collaborating, proofreading and formatting on documents

• Maintain files and control access to all original records and documents

• Assist in developing and improving the document control and change management system to support regulatory requirements

• Perform document control reviews on quality system records

• Perform reconciliation and filing of documents

• Distribute latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution

• Perform scanning and archiving of documents

• Lead record coordination and provide support during regulatory agency and customer audits

• Conduct training as required

• Act as lead for Document Control related projects

• Perform investigation report writing

• Maintain regular and punctual attendance
• Must maintain company quality and safety standards

Qualifications:
• Undergraduate degree in any Life Sciences, Engineering, or Management field or 6 years direct, relevant experience in Document Management to provide a comparable background

• Minimum of 1-3 years' experience in Quality Assurance or Document Control preferred
• Must possess excellent organizational skills and the ability follow complex processes, procedures and systems

• Proficient knowledge of Microsoft Office software, and other general office equipment.

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

• Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

• Must maintain a high level of professionalism, business acumen
• Must have effective verbal, written and interpersonal skills
• Ability to work in collaborative and independent work situations and environments with minimal supervision

Physical Requirements:

• Lab / Non-Production Setting: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.

• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

• Ability to work under specific time constraints.

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

• Visual and manual acuity for working with computers and equipment.

• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.

• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.

• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.