QC Lead, Molecular Diagnostics & QA

MMQCI-Maine Molecular Quality Controls Inc.; Saco (ME); On-site; USD 66,000 - 124,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Profit sharing

Paid time off

Parental leave

Job summary

Maine Molecular Quality Controls, Inc. (MMQCI) in Maine seeks a Quality Control Technical Lead to oversee QC release testing on molecular diagnostic products, analyze data trends, and troubleshoot instrumentation while ensuring timely QC deliverables.

The role requires a strong background in clinical molecular lab techniques, cross-functional collaboration, and adherence to cGMP/ISO/CLIA standards. Supervisory duties and customer support may be involved.

Qualifications

• MS in Biology/Life Sciences with Molecular Biology focus or BS with extended experience.
• Experience in molecular diagnostic lab or medical device testing environment.
• ASCP MT certification strongly preferred.
• Strong data analysis and problem-solving skills.

Responsibilities

• Mentor and train staff in molecular QC methods and testing.
• Coordinate QC testing for product releases and investigations.
• Review and improve QC SOPs.
• Lead root-cause investigations and CAPA projects.
• Coordinate transfer of new products from R&D to QC.
• Ensure contamination control and aseptic practices in the lab.
• Present data clearly and support cross-functional teams.

Skills

Molecular biology assays

Lab proficiency

Root-cause investigations

Project leadership

Statistical analysis

Pipetting accuracy

Data communication

Quality systems (cGMP/ISO/CLIA)

Education

M.S. in Biology/Life Sciences (Molecular Biology focus)

3+ years related experience

B.S. with 6+ years related experience

Tools

JMP

Job description

Maine Molecular Quality Controls, Inc. (MMQCI) in Maine seeks a Quality Control Technical Lead to oversee QC release testing on molecular diagnostic products, analyze data trends, and troubleshoot instrumentation while ensuring timely QC deliverables.

The role requires a strong background in clinical molecular lab techniques, cross-functional collaboration, and adherence to cGMP/ISO/CLIA standards. Supervisory duties and customer support may be involved.