The Senior Specialist, Lab Services is responsible for planning, coordinating, and/or implementing initiatives that provide quality assurance support for QC Lab Operations. Specific areas of support may include: GMP/Compliance; Change Management, Lab Equipment/Instrument procurement, installation, calibration, validation/qualification, Training and other QC Lab support projects. This position will help to ensure that the QC Labs operate in compliance with corporate and governmental regulations.

Responsibilities

• Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management regarding compliance concerns, ensure lab managers complete quarterly LIR and data review checklists, and serve as coordinator for any lab specific audits as needed.
• Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed.
• Serve as calibration coordinator for lab including approval and scheduling of service requests, impact assessment of demand maintenance on instrument qualification status, assignment, review, and approval of instrument related investigations, and creation of workorders in Maximo to capture vendor visits/maintenance as well as adding new instruments and decommissioning old instruments as needed.
• Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated and qualified according to company procedures.
• Perform assessments of QC documents (i.e. methods, qualification protocols, calibration documents, etc.) to determine compliance to processes and regulations to identify potential gaps. Mitigate and implement improvements within the quality system.
• Lead project teams in planning, preparation, review, and approval of quality documentation related to calibration requests.
• Participate on validation review board as area validation for equipment qualifications.
• Assist in the design of effective quality systems, procedures, and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• May be asked to assist in development, revision, or implementation (including delivering training) of training modules, videos, and documents to the local and to global labs.