Senior Analytical Scientist - QC Instruments - Onsite

Genesis10 is currently seeking a Senior Analytical Scientist - QC Instruments - Onsite for a contract position with a Global Medical Technology Company located in San Diego, CA. This is a 6+ month contract opportunity.

Pay range: $64.00 - $74.00 per hour

This role supports and strengthens the operational, compliance, and safety functions of the analytical laboratory. This position will focus on lab safety and instrument maintenance, instrument lifecycle management, and cGMP compliance readiness. The ideal candidate will act as the owner of instrument assets, collaborating with internal partners to ensure all equipment remains in a state of control and compliance.

Responsibilities:

• Lead new equipment onboarding and qualification (IQ/OQ/PQ coordination)
• Manage instrument maintenance programs, including preventive maintenance scheduling, service contract management, and vendor coordination
• Oversee instruments in the lab, which include calibration, PM, troubleshooting, new instrument induction, and qualification implementation and documentation
• Lead various analytical instruments qualifications with extensive experience on 21 CFR Part 11 compliance requirements
• Oversee laboratory software validation/qualification (e.g., CDS, LIMS, instrument software) and ensure compliance with data integrity principles
• Act as the primary point of contact with EHS and QA teams to ensure lab readiness for walkthroughs and audits
• Lead analytical lab relocation activities to ensure instruments are handled and qualified properly pre and post-move
• Oversee laboratory inventory systems, including chemicals, consumables, and standards

Requirements:

• Bachelor's degree or higher
• 5-8 years of related experience
• Must be proficient with both analytical instrument hardware and software qualification requirements 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
• Extensive experience with 21 CFR Part 11 compliance
• Hands-on experience with analytical lab relocation
• Effective technical writing skills, including the ability to write protocols, OOT investigations, and other technical reports
• Excellent interpersonal and communication skills with a demonstrated ability to coordinate and prioritize activities

Desired skills:

• Extensive hands-on experience with QC LIMS implementation
• Instrument lifecycle management and OOT investigation
• Documentation drafting and traceability

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.

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