Quality Documentation Specialist Jobs

The Quality Documentation Specialist (Specialist) is a member of the Quality Operations team and will report directly to the Director of Quality Operations. The Specialist serves as the point of control for the generation, maintenance, archival and retrieval of regulated documents for all cGMP and nonGMP activities.

Responsibilities:

• Manage and track the calibration and preventative maintenance programs
• Coordinate training and/or assist in training technical staff as needed
• Issue and revise SOPs
• Assist with creating CoAs and CoCs
• Assist in the preparation of validation protocols and reports
• Log and track all environmental monitoring results
• Issue and revise controlled forms
• Maintain and archive all regulated documents
• Maintain training data base
• Assign controlled documents numbers
• Initiate, log, and track change control
• Create and revise specifications
• Serve on SHE Committee and participate in safety walk-throughs, as needed
• Assist with tracking and trending quality metrics
• Assist the Director of Quality, as needed
• Issue and revise batch records
• Issue and revise cleaning records
• Issue and log controlled forms
• Initiate and track Notification of Events (NOE) and Out of Specification (OOS) documents

Qualifications and Requirements:

Required:

• Computer skills sufficient to discharge the duties of the position including but not limited to word processing, spreadsheets, presentation (Microsoft® Word, Excel, PowerPoint,), and various database programs.
• BS or BA and experience or combination of training and experience sufficient to discharge the duties of the position.
• Previous experience in working with people in a multi-disciplinary team environment.
• Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables.
• Communication Skills - ability to expresses oneself clearly, concisely, and effectively to associates, customers, suppliers, and partners over the phone; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience.
• Respect for Others - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
• Teamwork - the ability to work well with and assist personnel in a highly cross-functional team environment.

Preferred:

• Advanced usage of Microsoft Word.
• Previous experience in the documentation, operation, maintenance, calibration, and validation of laboratory equipment in a regulated laboratory environment.
• Previous experience with FDA, cGMP and GLP regulations as they relate to a controlled laboratory and manufacturing environment.
• Proficiency with technical editing and use of style guides (ACS).
• Previous direct experience with interactions with regulatory agencies.