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Specialist, QC Instrument Management
- Provide oversight as Validation Manager and support the implementation and maintenance of company's Instrument Maintenance program.
- Responsible for training site staff involved in Instrument Maintenance program, as required. Will be a point of contact when working with internal partners.
- Support QC SME for Data Integrity initiatives, continuous improvements, and related activities
- Support QC customers in validation of new lab equipment, or decommission of existing equipment/instrument in QC as the Validation Manager.
- May be required to complete validation for new equipment or existing equipment by creating test protocols and gathering requirements (URS, FRS, SDS, RTM, IQ, OQ/PQ)
- Support gap assessment of existing lab instruments/software used in QC per 21 CFR Part 11/Annex 11 and any remediation activities
- Bachelor's Degree in Biopharmaceuticals, Chemistry, or Biology (or closely related degree) with 5 + years of relevant industry experience.
- Advanced knowledge of validation of new equipment/instruments, changes to existing equipment/instruments, and/or decommissioning equipment/instruments; includes experience with system life cycle documents.
- Experience validating or maintaining the following instruments: HPLC, UPLC, Capillary Electrophoresis, UV-Vis, TOC, Liquid Particle Counters, Microplate Readers, PCR System, FTIR, Mass Spec, Cell Counter
- Experience validating or maintaining the following Software: Empower CDS, SoftMax Pro, 32 Karat, ChemStation, Biacore T200, DataPro2, LabWare LIMS
- Experience implementing and maintaining Instrument Maintenance program.
- Experience with Data Integrity and continuous improvement (data mapping, gap assessments, remediation). Experience remediating lab equipment, process, and software systems in compliance with 21 CFR Part 11 and GLP regulations.
- Experience leading projects with history of achieving results and outstanding outcomes.
- Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues. Including but not limited to 21 CFR Part 11 and Annex 11.
- Project management experience with the ability to manage multiple projects against given time-lines.
- Excellent interpersonal, organizational, and time management skills with ability to manage multiple priorities to accomplish objectives and goals.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands provide direct hire, executive search, temporary staffing, contract consulting and temp/contract-to-hire solutions to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Pharma and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
We look forward to working with you!
Beacon Hill. Employing the Future™
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