Laboratory Manager, Regulated and Responsible Person

Job Title: Manager, Regulated Laboratory & Responsible Scientist

Department: Regulated Laboratory 
Location: Onsite, 200 Precision rd #200, Horsham, PA 19044
Hours Per Week: 40 hours
Schedule: Days, Monday – Friday

SUMMARY 
The Manager, Regulated Laboratory & Responsible Person (RP). The Manager, Regulated Laboratory is responsible for oversight and management of the Regulated Department. They will work collaboratively with the Laboratory Leadership Team and Lab Director to ensure quality and best practices in the laboratory. The Manager serves as the Responsible Person for the Regulated Lab; the RP is fully trained to understand laboratory operation and to thoroughly understand HHS Guidelines, Program Documents and the NLCP Manual for Urine Laboratories.
 

RESPONSIBILITIES 

• Manage operations of the Regulated Laboratory in collaboration with the Director and site Leadership team.
• Oversee daily activities of the laboratory staff.
• Hire, monitor, train, and supervise staff to ensure compliance with corporate policies, department policies and procedures, current guidelines for SAMSHA/CAP/CLIA/NCLP, any state, federal or national regulations and any other legislation or regulation that is relevant.
• Ensure maintenance and storage of regulated laboratory records; liaise with record storage vendor as necessary.
• Ensure laboratory equipment is operational and ensure ongoing maintenance. Research and make recommendations for new capital equipment, and contracts for reagents and instrumentation.
• Review, interpret and monitor compliance with pertinent regulations/standards (SAMSHA/CAP/CLIA/NLCP). Interact with regulatory agencies as needed. Review departmental policies and procedure manuals to maintain regulatory compliance.
• Ensure Standard Operating Procedures are current, available, and followed by all personnel.
• Ensure that chain of custody procedures are followed by all personnel.
• Oversee Quality Control and proficiency testing processes. Ensure completion of competency assessments.
• Provide continuing education and training opportunities to laboratory staff, other corporate personnel, and external customers.
• Prepare and monitor budgets and operational costs; uses financial information to assist in decision making regarding staffing levels, workload and process management. Provides, analyses, and updates key performance metrics accordingly.
• Liaise with Management and Finance to ensure the most cost-effective contracts for materials supply in addition to maintenance, calibration and repair of equipment are established and maintained.
• Provide oversight of monitoring, and analysis of departmental QA indicators. Initiate plan of corrective action if needed. Communicate QA outcomes to appropriate individuals and departments. Participates in audits as required.
• In conjunction with the Laboratory Leadership, identify/support new areas of corporate growth.
• Prepare literature packets for evidence and/or testimony as requested.
• Consults with clients as necessary.
• Support Negative Certifying and/or Non-Negative Certifying as required.
• Ensure the Alternate Responsible Person is able to manage operations in Responsible Person’s absence.
• Fully understand the LIMS and other computer systems in specimen receipt, accessioning, chain of custody, testing, review and reporting of results.
• Understand thoroughly the HHS Guidelines, Program Documents and the NLCP Manual for Urine Laboratories, and takes responsibility for corrective actions in response to issues identified during inspections and with proficiency testing failures.
• Perform all other duties as assigned by supervisor/management.

REQUIRED QUALIFICATIONS

• Ph.D. in one of the natural sciences and 3 years’ experience required OR Master’s degree in one of the natural sciences and 5 years’ experience required OR Bachelor’s degree in chemical, biological sciences, medical technology or equivalent plus 10 years’ experience required.

PREFERRED QUALIFICATIONS

• Board Certification: ABFT, ABCC (Toxicological Chemistry) preferred.

PHYSICAL REQUIREMENTS:

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.