Metrology Specialist
4 weeks ago
IntePros is seeking a skilled Metrology Specialist to support the quality management system for laboratory instruments. The ideal candidate will have experience with validation and calibration, as well as a strong understanding of cGMP regulations.
Key Responsibilities:
- Create electronic instrument equipment validation plans in tracking and approval systems.
- Develop documentation and revisions to support the quality management system for laboratory instruments.
- Provide input and support to maintain project schedules and activities for new instrument installation projects.
- Review and manage instrument repair documents for compliance to work instructions.
- Support audits, including regulatory, customer, and quality management system audits.
- Write installation qualification (IQ) documents, operational qualification (OQ), and process qualification (PQ) validation documents for new laboratory instruments.
- Develop documents such as laboratory investigations, work instructions, and procedures.
- Provide updates to weekly instrument meetings on the status of documents and activities.
- Responsible for data input into SAP equipment, calibration, and maintenance module.
- Develop key validation documents using functional, user requirements, design specifications, equipment manuals, and risk assessments for fully compliant GMP instruments.
- Support and maintain the instrument quality program, including annual installation qualifications, preventative maintenance documentation, and instrument asset life cycle management.
- Collaborate with lab employees, onsite contractors, and outside vendors for repair and installation of lab equipment.
- Stay current with new technologies and cGMP regulations.
- Support the Lab Metrology group with other activities and projects as needed.
- Perform follow-up activities for metrology area of work.
Requirements:
- Bachelor's of Science degree in a related area.
- 3 years of documentation and validation experience in the pharmaceutical industry.
- Strong understanding of cGMP regulations and quality management systems.
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