Clinical QA/QC Specialist

COMPANY OVERVIEW:

As the world’s largest university-based biorepository, Infinity BiologiX has been perfecting the science of biobanking, bioprocessing and analytics since 1999. By utilizing a technologically advanced infrastructure and the highest quality biomaterials, IBX scientists work to convert precious biosamples into renewable resources thereby extending research capabilities. IBX understands that research goals and objectives vary from project to project so we give each client individually and customized attention to ensure “best fit” service.

POSITION SUMMARY:

The Clinical QA/QC Specialist assists in all activities and administrative duties for projects involving clinical sample processing. This involves tracking Quality Indicators, FQC and AQC Data Review, Inspection Readiness – State, Federal, CAP, Training Records, Competencies, Proficiency Testing, SOPs, logbook reviews, and any activity involving a clinical-grade assay run at IBX.

RESPONSIBILITIES INCLUDE:

· Supporting managers in maintaining State, Federal, and CAP Inspection Checklists and ensuring licensures are kept up to date.

· Supporting managers and supervisors running clinical-grade assays by ensuring all Quality Indicators are being monitored, training records/competencies are up to date, SOPs are being followed, and Proficiency Testing is being implemented.

• Working with QA Team and Analytical and Clinical Services Teams to ensure the lab is maintaining logbooks and maintenance records.
• Working as part of an internal audit team to review regulatory compliance of various lab areas.
• Conducting data review and alerting managers and project managers about nonconformance data, along with documenting the process via a CAPA.
• Performing and/or supporting investigation of quality events.

COMPETENCIES:

· Excellent verbal and written skills.

· Good communication skills required, both with internal team members and managers.

· Be able to maintain strict organizational skills.

· Work independently to solve technological and analytical problems.

· Knowledge in FQC and AQC data review.

QUALIFICATIONS:

• This position requires a BA/BS in life sciences with at least 1 year of experience in molecular biology.
• This individual must have experience in basic molecular biology techniques.
• A background in either Quality Assurance, Regulatory Affairs, or Health Care Administration is desired.
• Certified Lean 6 Sigma Green Belt preferred.

· Solid knowledge of relevant regulatory standards.

• Excellent data collection and analysis skills.
• Strong attention to detail.

Job Type: Full-time

Pay: $45,000.00 - $60,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Molecular biology: 1 year (Required)
• Quality assurance: 2 years (Preferred)

License/Certification:

• Lean 6 Sigma Green Belt Certification (Preferred)

Shift availability:

• Day Shift (Required)

Work Location: One location