QC Analytical Instrumentation Specialist

Proclinical is seeking a QC Analytical Instrumental Specialist for a global pharmaceutical company located in Lexington, MA.

Must be eligible to work in the US.

Job Responsibility:

• Support QC analytical instrumentation/equipment validation life cycle and executing these activities under GMP compliance
• Gap assessment and remediation
• Support QC lab renovation/equipment relocation and equipment qualification activities'
• Project Manage the QC Equipment Validation projects
• Document analytical equipment qualifications in written reports and procedures, i.e. URS, Trace Matrix, System Categorization, DQ, IQ/OQ/PQ, and decommissioning documents.
• Support QC analytical instrument/equipment decommissioning.
• Determine max loads for temperature mapping of QC environmental chambers
• Identify the need for process improvements and assess/drive new analytical technologies or processes that would improve throughput and time savings.

Skills and Requirements:

• Bachelor's degree required
• 5+ years of related experience
• CGMP knowledge
• Software experience using MS Office, ValGenesis, TrackWise and EDMS

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at +1 (215) 531-6914 or s.briggs@proclinical.com.

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

Proclinical Staffing is an equal opportunity employer.

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