Under the direction of the QA Document Control Supervisor, the QA Specialist – Document Control, will control the movement, filing, archiving, and securing of all documents with the objective of ensuring compliance to company policies and procedures. In addition, the QA Specialist will review, issue, and reconcile controlled documents according procedures.

• Maintain quality system controls to ensure state of compliance
• Take appropriate steps to reduce wastages and losses in the process and build improved efficiency
• Under guidance of the Senior QA SpecialistDocument Control, the QA Specialist - Document Control will:
  • Respond to Document Control related activities throughout the site
  • Issue and reconcile controlled documents, process records for archival, retrieve documents as requested
  • Follow procedures as they relate to doc cell security and maintenance
  • Perform document review
  • Perform document implementation processes (Set Date)
  • Execute activities within the Document Management Systems in a compliant manner
  • Assist in the implementation of all new electronic systems for document management.
• Other duties as required
• Support all cross functional teams within the site for document control related needs
• Support regulatory inspections and audits
• Maintain documents per guidelines to ensure quick retrieval

• Assist in implementing systems to enhance document management process and daily operation.

Knowledge and Skills

• Must be proactive, results oriented, with a strong attention to detail.

• Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.

• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.

• Excellent verbal and written communication. Must be able to read, write, and speak English.

• Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.

Knowledge of /or SAP (Systems, Applications & Products in Data Processing), MasterControl, Trackwise, is a plus.

Leadership / Managerial Attributes

• Strong organizational, troubleshooting and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.

• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.

Other requirements (licenses, certifications, specialized training)

• Good communications skills

• GMP trainer a plus.