Job Title
Senior Calibration & Laboratory Specialist
Requisition
JR000014605 Senior Calibration & Laboratory Specialist (Open)
Location
Hazelwood, MO
Additional Locations
St. Louis, MO
Job Description Summary
Job Description
The Senior Calibration & Laboratory Specialist will be responsible for managing and maintaining the metrology program, support and perform the validation and qualification of the instruments and provide analytical support for development programs within the Global Technical Operations organization. The position will be responsible for reviewing and updating applicable standard operating procedures. In addition, the position will provide routine support to ensure the continued operation of the laboratory. This individual will ensure timely execution of deliverables and that the quality of data and documentation conforms to established standards.
Essential Functions
Provide analytical support for development projects, including HPLC, LCMS, GC, etc.
Calibrate and maintain critical laboratory equipment, including thermometers, pH meters, JKems, UV spectrophotometers, and balances.
Oversee the temperature monitoring of all freezers and refrigerators, managing the Labwatch and Smart-Vue temperature monitoring systems, as well as chart recorders; Lead investigations into temperature excursions and manage the appropriate storage of chemicals in affected refrigeration units.
Manage Asset Management and Tracking, Transcat software for lab equipment inventory, ensuring timely calibration for instruments used in producing reference standards.
Arrange necessary services to ensure that lab equipment remains within calibration standards.
Review and update Standard Operating Procedures (SOPs) and lab equipment logbooks.
Provide troubleshooting support for lab equipment, including the reference standard synthesizer and HPLC systems.
Manages software for chemical inventory and performs HPLC calibrations.
Participate in routine laboratory equipment logbook reviews to maintain compliance within the Reference Standards Program.
Perform essential tasks such as washing glassware, disposing of waste, and managing the supply of dry ice, lab coats, PPE, gas cylinders, and liquid nitrogen.
Maintain the DI water system and fume hoods, ensuring that all necessary services are arranged promptly.
Coordinate and escort contractors and service engineer, provide training to site visitors, and manage shipments received.
Education / Experience / Skills:
Associates degree with 8+ years of pharmaceutical or related work experience in field.
Bachelors degree with 5+ years of pharmaceutical or related work experience in field.
Masters degree with 3+ years of pharmaceutical or related work experience in the field.
Familiarity with requirements of various pharmacopeias (USP, EP, JP) and basic regulatory requirements and applies knowledge appropriately to activities.
Familiarity with GLP and GMP working environment
Demonstrates proficiency in Microsoft Word, MS Project, Excel, Power Point, and Adobe.
Self-starter with strong work ethic, excellent written and verbal communication skills; the ability to successfully conduct or manage various synthetic projects in a timely manner.
Demonstrates strong organizational and planning skills; excellent interpersonal skills with ability to work in a team environment and operate with limited supervision.
Demonstrates capability and comfort in communicating and interfacing with all levels in the organization including management and senior management.
Demonstrates high level of customer focus
Preferred Skills/Qualifications:
Experience and knowledge of pharmaceuticals is preferred.
Experience and knowledge of metrology
Practical experience in analytical chemistry and associated analytical equipment.
Organizational Relationship/Scope:
Position directly reports to the Sr. Manager, Analytical Chemistry.
This position requires frequent work in a research laboratory, both standing at a bench and seated. It also requires reaching into flammable cabinets. This position involves frequent work in an office environment, using a computer to analyze data, write reports, and document experiments in notebooks. Occasional travel may be required for engagement with external laboratories and collaborators.