POSITION TITLE: Senior Metrologist
REPORT TO: VFC Supervisor
SUPERVISES/DIRECTS: Support Staff as project or work conditions require
Provide oversight of daily metrology operations including design, development, implementation and maintenance of validation programs, calibration processes, hands-on calibration and repair, ensuring that all cGMP requirements are satisfied.
- Design, execute, and implement various protocols in compliance with IQ/OQ/PQ (Installation Qualification / Operational Qualification / Performance Qualification) requirements related to quality control / quality assurance manufacturing activities.
- Provide hands-on calibration, repair and technical support for various quality assurance manufacturing activities or systems such as WFI, air handlers, autoclave, etc. in compliance with cGMP and industry guidelines.
- Administrator for the Calibration Program, reviews and approves all Certification Reports.
- Write and review CAPAs and QA Investigation Reports related to calibrations and validations.
- Develop calibration test methods, SOPs, and reports.
- Provide technical training while qualifying and ensuring that all staff adhere to safety protocols and cGMP requirements to comply with FDA and ISO standards. (Qualified Trainer)
- Prepares system documentation, including user requirement documents, specification document, test plans and user manuals for instrumentation.
- Assists in interpreting and selecting measurement and calibration options that provide required accuracy.
- Perform Data Integrity/System Audit Trail Review functions for Instrumentation and conduct internal audits of Metrology documentation.
- Ability to participate in vendor, client, internal and FDA audits, and generate the appropriate documentation required.
- Responsible for ensuring service vendors performs installation, repair and preventive maintenance of GMP and Research laboratory Instrumentation and equipment in accordance with client SOPs.
- Perform all duties and all quality assurance / validation activities according to the applicable guidelines, i.e. FDA, GMP, ICH etc.
- Ability to initiate problem-solving and technical decision-making commensurate with level of experience.
- Written and oral skills at a level commensurate for interaction with staff, vendors and clients as necessary.
- Direct, plan, design, and coordinate development project activities.
- Provide technical expertise to all project activities. Participate in short-and long-term strategic planning.
- Perform other related duties and responsibilities as assigned.
- Bachelor’s Degree in Engineering or science field or equivalent and relevant formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 to 7+ years) or equivalent combination of education, training, and experience OR Master’s Degree
- Understanding of FDA and cGMP regulations and requirements
- Working knowledge and understanding of laboratory instrumentation and equipment.
- Working knowledge with systems in use within the Pharmaceutical industry
- Ability to train others
- Analytical and critical thinking skills
- Trouble shooting abilities
- Ability to communicate effectively with vendors, and all levels of staff
- Ability to work in a collaborative team environment
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .