Senior QC Instrument Scientist

Genesis10 is currently seeking a Senior QC Instrument Scientist for a contract position with a Leading Medical Device Company located in San Diego, CA. This is a 6-month contract opportunity.

Compensation: $70.00 -76.00 per hour, W2

This role is to support and strengthen the operational, compliance, and safety functions of the analytical laboratory. The position will focus on lab safety and instrument maintenance, instrument lifecycle management, and cGMP compliance readiness.

Responsibilities:

• Lead various analytical instruments qualifications with extensive experience on 21 CFR Part 11 compliance requirements
• Act as owner of instrument asset from analytical team to collaborate with internal partners on appropriate instrumentation lifecycle management
• Oversee instruments in the lab, which include calibration, PM, troubleshooting, new instrument induction and qualification implementation and documentation
• Understand software 21 CFR Part 11 server IT requirements and hardware/software documentation requirements for QC purposes
• Draft user requirements specification, performance qualification protocol and hardware/software validation protocol and report
• Act as primary point of contact with EHS and QA teams to ensure lab readiness for walkthroughs and audits
• Lead analytical lab relocation activities to ensure the instruments are handled and qualified properly pre and post move

Requirements:

• Bachelor's degree in a technical discipline
• 5-8 years of related experience
• Proficient with both analytical instrument hardware and software qualification requirements and activities for instruments like GPC-MALS, HPLC-ELSD, LC-MS, GC-FID/MS, FTIR etc.
• Extensive hands-on experience with analytical instrumentation operation, troubleshooting, maintenance and repair
• Effective technical writing skills, including ability to write protocols, OOT investigations, and other technical reports and documents
• Excellent interpersonal and communication skills with demonstrated ability to coordinate and prioritize activities
• Extensive hands-on experience with QC LIMS implementation to connect analytical instruments with report exporting as well as centralized data management

Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client.

Benefits of Working with Genesis10:

• Access to hundreds of clients, most who have been working with Genesis10 for 5-20 years.
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
• Behavioral Health Platform
• Medical, Dental, Vision
• Health Savings Account
• Voluntary Hospital Indemnity (Critical Illness & Accident)
• Voluntary Term Life Insurance
• 401K
• Sick Pay (for applicable states/municipalities)
• Commuter Benefits (Dallas, NYC, SF, and Illinois)

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.

Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.