Sr. Specialist, Quality Control, Equipment SupportApply Now
Location: Norwood, Massachusetts 02139
Employment Type: Contract
Contract Length: 6 months
Job Summary: The individual in this role will focus on support and upkeep of the QC equipment lifecycle. The individual will coordinate across multi-discipline teams to meet business objectives and may support Investigations for Quality Events.
- As part of the QC team, your primary responsibilities will be as follows:
- Monitor and communicate Instrument lifecycle (asset induction, move/decommission, CQV activities, etc.) timelines using project management tools
- Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors as well as onsite support
- Support instrument/equipment needs of QC laboratory including the Microbiology, Analytical, and Sample management, Raw Materials departments
- Manage and own quality systems records such as deviations, change controls, CAPAs from start to finish
- Support efforts for method troubleshooting, remediation, change, and optimization efforts in cross functional teams
- Author, update, and maintain Equipment/Instrument SOPs
- Minimum education required: Bachelor’s degree in relevant sciences and 3-10 years of industry experience in a cGMP laboratory setting. Level determined by experience
- Strong technical background in Microbiology and/or Analytical Instrumentation/Software, Metrology, method acquisition and instrument troubleshooting.
- Demonstrate ability to problem solve, organize, and see-through project timelines independently
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- Strong technical writing skills, oral communication and organizational skills.
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