Quality and Compliance Manager

Position Summary:

Cordant Health Solutions has an immediate opening for an experienced Quality and Compliance Manager to join our growing team at our lab in Indianapolis, IN. This position assists the Lab Scientific Director and General Manger, Indianapolis Laboratory with laboratory quality initiatives as well as day to day quality, compliance, and safety programs. This position is responsible for maintaining the laboratory?s inspection readiness program, and all documents/programs associated with maintaining accreditation with various agencies. This position also acts as a Safety Officer and ensures the safety of the laboratory work environment as well as compliance with CLIA, CAP, and OSHA safety principles.

The schedule for this role is Monday - Friday 8:00am-5:00pm, depending on business needs.

Salary: $65K - $75K

Essential Functions:

• Ensure continued compliance with quality systems management objectives

• Performs or assists in performing weekly and monthly QC reviews through Levy Jennings reports in both

Screening and Confirmation departments, performs instrument performance and QC comparisons, and

identify trends for errors and performance in data review and analysis

• Maintain document control related to personnel competency assessment program

• Assists in completion of employee records files and audits for completion

• Act in the role of Safety Officer maintaining chemical inventory and ensuring availability of safety data

sheets (SDS) and lead periodic safety meetings

• Review, process, and submission of results for Proficiency Testing (PT) programs. Complete all records

and documentation associated with each PT cycle, including PT performance assessment and corrective

action investigation in an event when a result is outside of an acceptance range.

• Advise Management team with regards to OSHA and regulatory compliance

• Lead (Corrective action and preventative action) CAPA and Technical investigations (TI) in coordination

with laboratory management and Lab Scientific Director to ensure complete root cause analysis, and

effective corrective action implementation

• Participate in preparation for state and accreditation inspections and participate in inspection interviews

• Participate in QA internal audits and external inspections, documenting findings and facilitating timely

corrective/preventative actions

• Participate in QA/regulatory review of standard operating procedures, protocols, and technical

documentation

• Maintain stringent standards for quality, identifying any issues which might adversely impact the quality

of test results and/or employee safety, mitigation of risks, and immediately communicating these to

management

• Maintain Laboratory Certifications/Licensure

• Review and approve supplemental logs, charts, and other documents in the QA process

• Assist in investigations including nonconformance, and complaints

• Prepare and lead monthly quality meetings and record meeting minutes

• Prepares monthly quality packets for Scientific Director review, including but not limited to all maintenance logs, temperature logs, safety logs, and QC analysis

• Directs efforts towards production areas that need assistance

Additional Duties:

• All other duties as assigned

Education and Experience:

• BA or BS, or higher, in Chemistry, Biochemistry, Biological Science, or related discipline required.

• One year of relevant laboratory experience required.

• Experience in a QA function in a high-complexity clinical laboratory is preferred.

• Experience participating in the CAP-FDT and/or CLIA programs is preferred.

Knowledge, Skills, and Abilities:

• High degree of computer literacy

• Knowledge of Clinical Laboratory Improvement Act (CLIA) and College of American Pathologists (CAP),

highly desirable

Physical Requirements:

• Light to moderate physical effort (lift/carry up to 25 lbs.) -Heavier weights with assistance

• Sitting & standing for extended periods of time

• Repetitive motions and/or prolonged computer use

Benefits

Cordant supports our employees by providing a comprehensive benefits package to eligible staff (per state regulations) that includes: Medical, Dental, Vision Insurance, Flexible Spending Accounts (FSA), Health Savings Accounts (HSA) Paid Time Off (PTO) accruing on day 1, Volunteer Time Off (VTO), Paid Holidays, 401(k) with Company Match, Employee Assistance Program (EAP), Short Term and Long-Term Disability (STD/LTD) and Company Paid Basic Life Insurance.