The QA Documentation Coordinator  supports the assigned Quality Assurance team in numerous areas

including document archive management, data entry and trending, GxP documentation management

and general office support. Performs miscellaneous job-related duties as assigned and cross trains to be

able to back up other team members.

This role ensures that all QA documentation activities are in compliance with company SOPs, GMP/GLP

standards and client requirements. Ability to work within a dynamic and fast paced environment.

Responsibilities

Organize and inventory records in a manner that provides efficient and effective viewing and

retrieval including but not limited to: testing records, training records, and equipment records.

• Provides general office support including but not limited to: scanning records, sending records toclients, filing hard copy records, reconciling records, retrieving records and archiving records.
• Assigns controlled document numbers, as required.
• Works with QA team to track trending data.
• Updates and maintains GxP documentation in applicable software
• Manage the logbook request forms, bind approved logbooks and distribute as needed
• Support Quality project initiatives
• Is the resource for all QA documentation support activities and may train others on processes asneeded.
• May be asked to perform additional duties in assigned and unassigned areas.
• Under manager supervision, able to comply with GMP, SOPs and basic regulatory guidance.
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Ability to participate in internal, client and/or regulatory audits.
• Effectively coordinates and organizes tasks to help drive the activities of the department; while performing a variety of duties on schedule, with accuracy and competency.
• Ability to take direction from others and contribute in a team environment.

Qualifications/Skills

• Detail-oriented, organized and applies effective time management skills in order to meet all deadlines.
• Able to successfully prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction.
• Promote a safe environment for work.
• Ability to document all work activities clearly and concisely in a timely manner utilizing existing forms and records. Writes legibly.
• Communicate clearly and effectively both orally and in writing with internal and external clients.
• Basic Understanding of current FDA and GMP / GLP regulations.
• Basic knowledge of MasterControl, Trackwise and/or other QMS software applications, preferred.
• Perform basic math functions to include product accountability and material adjustment calculations and rounding

Skills / Abilities:

• Ability to learn and apply GMP and SOP concepts during day-to-day processes.
• Communicate clearly and effectively both orally and in writing with internal and external clients.
• Ability to work across numerous scientific and management disciplines.
• Good Computer Skills
• Microsoft Suite, proficiency

Education, Experience & Licensing Requirements

• High school diploma required or AAS degree, preferred.
• 2+ years of office experience and/or regulated work experience.

Supervision Received: General Supervision Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.

Travel: Not Applicable

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.