Quality Documentation Specialist
Company: CritiTech Particle Engineering Solutions
Posted on: May 23, 2023
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.
- Maintain and archive all regulated documents
- Manage and track the calibration and preventative maintenance
- Log and track all environmental monitoring results
- Issue and log controlled forms
- Initiate, log, and track change control
- Issue and revise SOPs
- Issue and revise controlled forms
- Maintain training data base
- Issue and revise batch records
- Issue and revise cleaning records
- Assist with creating CoAs and CoCs
- Assist with tracking and trending quality metrics
- Create and revise specifications
- Assign controlled documents numbers
- Initiate and track Notification of Events (NOE) and Out of
Specification (OOS) documents
- Assist in the preparation of validation protocols and
- Serve on SHE Committee and participate in safety walk-throughs,
- Coordinate training and/or assist in training technical staff
- Assist the Director of Quality, as needed
Qualifications and Requirements: Required:
- 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.
- 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.
- Teamwork - the ability to work well with and assist personnel
in a highly cross-functional team environment.
- 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.
- Knowledge Sharing - ability to capture knowledge within the
organization; improves solutions, processes, and deliverables.
- 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
- Previous direct experience with interactions with regulatory
- Advanced usage of Microsoft Word.
- Proficiency with technical editing and use of style guides
Keywords: CritiTech Particle Engineering Solutions, Lawrence , Quality Documentation Specialist, Other , Lawrence, Kansas
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