Senior Quality Specialist I, Metrology
The Senior Quality Specialist I, Metrology will administer metrology program, maintain equipment in LIMS, provide schedules for activities, review supplied documentation, author program procedures, and ensure compliance to regulations and written procedures. Will also provide system metrics including usage, downtime, and reliability and develop a system retirement strategy and 5-year laboratory instrument requirements plan.
- Administer metrology program, maintain equipment in LIMS, provide schedules for activities, review supplied documentation, author program procedures, and ensure compliance to regulations and written procedures. Provide system metrics including usage, downtime, and reliability.
- Manage projects involving computer system validation as it relates to laboratory systems and the data integrity of electronic data. Work in a cross-functional team on GAMP 5 validation projects to deliver laboratory instrument/software.
- Perform Preventative maintenance and real time repair for laboratory equipment including Sotax automated systems. Ability to read schematics and perform repairs and maintenance with minimal downtime. Ability to determine validation impact of repairs and perform required change controls in TrackWise.
- Perform maintenance, calibration, qualification, repair and troubleshooting on a variety of laboratory instruments including but not limited to HPLC, GC, TPW3, Automated Dissolution Systems, UV spectrophotometers, Balances, and pH meters and other special purpose lab equipment.
- Provide time trending and task data; assist with departmental scheduling; manage scheduling spreadsheets to ensure that they are complete and understood and to provide detailed status reports to management.
- Develop, author or revise, and follow strict protocols for instrument installation, operation, and performance qualification.
- Coordinate new instrument installation, calibration and repair with technical groups and vendor; ensure appropriate documentation is in place; communicate with vendors and service personnel regarding instrumentation issues; review vendor qualification protocols and final reports for accuracy, completeness and compliance.
- Assess current vendor calibration programs for performance, applicability and return on investment.
- Assist with assessment of new technology and instrumentation for the labs.
- Assist with laboratory investigations involving equipment failure, including impact assessment.
- Train laboratory personnel or other metrology personnel in metrology activities, as appropriate.
- Maintain the laboratory instrumentation with minimal downtime while adhering to all compliance requirements.
- Implement new instrumentation and new technology in the laboratory including validation and qualification of systems.
- Collaborate closely with users/laboratory colleagues to resolve issues; Assist in setting priorities for problem resolution related to the instrumentation. Assist in investigations, including root cause analysis and CAPA plan.
- Write, revise, develop, evaluate and review Standard Operating Procedures for instrumentation.
Education and Experience:
- BS degree in Chemistry or other related science
- 8 years minimum experience or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 6-10 plus years experience or PhD with 3-6 plus years experience.
Necessary Knowledge, Skills and Abilities:
- A successful history in maintaining instruments is desirable.
- Direct experience in repair and maintenance of laboratory robotics equipment and metrology required for senior level position.
- Must have strong oral and written communication skills.
- The incumbent must be able to clearly identify problems or compliance issues arising from the assigned work and quickly implement solutions.
- Candidate must have a working knowledge of USP, FDA, cGMP, GAMP (particularly V-Model) and 21 CFR Part 11 requirements.
- Direct experience with documenting user requirements and functional specifications for laboratory instrument/automation systems preferred.
- Knowledge of LIMS, Quality Documentation Systems, Change Control, CAPA Laboratory operations, and Stability programs is highly preferred.
- Knowledge of HPLC, UPLC, Empower CDS, TPW3, MultiDose and other laboratory systems is required.
Physical and Environmental
- Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
- Lift and maneuver equipment and materials weighing up to 20 pounds.
- Take samples which may require stretching, bending, or twisting to remove product from the equipment and/or drums.
- Use small hand and power tools to perform incidental maintenance.
- Perform cleaning and assembly/disassembly on laboratory equipment which may require pulling, pushing, or twisting to remove equipment shields, parts and panels. Equipment and parts could weigh up to 20 pounds. Also requires operation of industrial hose (water) and physical exertion (repetitive wiping, rubbing and scrubbing) to clean equipment and laboratory surfaces.
- Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.