Senior Quality Control Analyst

Proclinical is advertising an exciting opportunity for a Senior Quality Control Analyst with an innovative biotechnology company that specialises in RNAi therapeutics. The Senior Quality Control Analyst will join this exciting company's team in Massachusetts in a contract role.

Job Responsibilities:

• Supporting QC lifecycle requirements for assigned projects to maintain holistic approach with QC Alewife, QCTS, and QC External.
• Ensuring QC Norton laboratory start-up is conducted in accordance with applicable SOPs, compendia, and in accordance with company and regulatory agency policies and procedures.
• Coordinating activities related to the qualification, calibration, and maintenance of laboratory equipment and related systems.
• Coordinating the purchase, commissioning, and introduction to service of new equipment.
• Establishing and maintaining Equipment History Files (EHF) for QC laboratory equipment.
• Establishing and maintaining Equipment History Files (EHF) for QC laboratory requirements.
• Preparing, reviewing, and approving laboratory documentation related to laboratory instrumentation and systems (e.g., SOPs, validation protocols, etc).
• Scheduling/planning/executing validation activities of new laboratory equipment.
• Ensuring the 21CFR compliance of all laboratory equipment and associated systems.
• Communicating inter-departmentally and with outside contacts to solve laboratory instrumentation issues.
• Participating on and/or representing QC on cross-functional teams.
• Starting up the QC laboratory be ensuring appropriate equipment lifecycle management.

Skills and Requirements:

• A bachelor's degree in a related field.
• At least 3 years of relevant experience.
• Demonstrable experience with managing life cycle equipment and functions.
• Demonstrable experience in the biotech or pharmaceutical industry.
• A strategic mindset, capable of formulating actionable financial analyses and seeing them through.
• Proficient with computer software.
• Strong interpersonal skills, focusing on communication, persuasion, and negotiation.
• A capability of communicating with various levels of management.
• An ability to work sensitively with confidential material.
• An ability to handle multiple assignments and managing competing priorities with tight deadlines.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Corrin Pyle on + 267-435-8555 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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