QA Documentation Clerk

RESPONSIBILITIES

• Organizes and maintain employee training documentation
• Scanning and storing of Quality records such as Batch Records, Deviations, CAPAs, Change Controls and Product Complaint Reports.
• Provide necessary documentation to support inspection activities.
• Assist in issuing, tracking, and storing all documentation
• Facilitates compliance with company documentation policy.
• Issue production batch records and supporting documentation needed for production execution.
• Coordinates and supports the operation, maintenance and improvement of document control system.
• Archive inactive records in accordance with the records retention schedule.
• Track and trend data to support Annual Product Quality Reports.
• Support the operation of an electronic document control/management system.
• Other duties will be assigned as required to support Quality Assurance.
• Must be computer literate, with experience in spreadsheet and database applications
• Must be detail oriented and well organized
• Must have the ability to work on multiple different tasks within a workday
• Must have a positive teamwork attitude
• Excellent interpersonal, oral, and written communication skills
• Maintains confidentiality of sensitive information
• Ability to meet attendance standards. All full-time employees are required to minimally work a 40-hr week. Sometimes it may be necessary to work additional hours to accomplish the required tasks to meet deadlines

QUALIFICATIONS

Education & Experience:

• Associate degree preferred.
• 5 years of pharmaceutical experience; or equivalent combination of education and experience.

Work Environment/Physical Demands:

• The employee may frequently be required to sit and talk or listen.
• The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, and crouch.
• The employee must occasionally lift and/or move up to 25 pounds.
• A cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves, and steel-toe boots be worn. Also, no makeup or jewelry can be worn when working in a clean room environment.

COMPENSATION: $20/hr.