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Quality Control Manager
  • Location: Harrisburg , PA
  • Type: Direct Hire
  • Job #14425

Position Summary:
Under the guidance of the Medical Director, the Quality Control Manager is responsible for ensuring all aspects of the quality control system are being performed per company procedures and regulatory requirements. The QC Manager must maintain patient and company confidentiality and adhere to all compliance, regulatory, and company procedures and policies.

Key Responsibilities:
– Prepare and analyze quality control section of the monthly report. Assure equipment maintenance is performed on a monthly basis including, but not limited to, temperature and humidity trends, OOS equipment, and cleaning and equipment maintenance performed on a monthly basis.

– Prepare quarterly Quality Report including all Quality Indicators

– Maintain non-conformance reports including, but not limited to, logging and relevant documentation and investigation.

– Qualify vendors for laboratory products.

– Track the receipt, quarantine, release and rejection of products. Obtain quality documents. Determine if a product should be released or rejected. Ensure products are properly labeled.

– Assist technologists with reagent qualification design

– Release reagents for use and update the Lot Number Log. Ensure all reagents used to manufacture products are appropriate in type, grade and concentration; and within expiration date. Ensure all reagent labeling is correct. Ensure the correct reagent expiration date is assigned to the manufactured reagent. Ensure all calculations used in manufacturing the reagent are correct.

– Design, analyze and prepare reports for process updates and validations.

– Organize proficiently testing sample exchanges 

– Organize and prepare credentialing and licensing renewals

– Prepare lab for biannual CAP and NY-DOH inspections.

– Responsible for laboratory Contamination Monitoring of bench area and equipment. Monitor the laboratory area and equipment temperature monitoring records.

– Point of contact for the emergency call when an environmental alarm is triggered by the electronic monitoring system.

– Monitor detergent residue testing results. Review the laboratory cleaning records. Audit cleaning logs and inform the Laboratory Supervisor if cleaning was not completed.

– Responsible for maintaining an inventory of current and retired equipment. Assign asset register numbers to equipment. Ensure equipment is calibrated and maintained per manufacturer’s recommendations. Obtain repair of broken equipment and make recommendations to the Laboratory Supervisor and Medical Director for new equipment when needed. Review equipment status forms, maintenance reports, calibration reports, cleaning check sheets, function check sheets, and OOS forms. File calibration certificates and equipment manuals.

– Responsible for facility safety management and reporting including, but not limited to, OSHA record keeping, monthly reporting, accident investigations and hazard analysis.

– Train staff on proper cleaning of laboratory area and equipment.

– Review and update Lab SOPs.

– All other duties as assigned.

Skills:
– Excellent judgment, organizational skills, and problem solving abilities.

– Capable of working independently and with a team. Ability to complete tasks on time with minimal supervision.

– Strong verbal and written communication skills.

– Basic computer skills-Microsoft Excel and Word and Adobe are required, LIMS preferred.

– Preferred experience with clinical sample processing.

– Required regulated environment experience (CLIA, CAP, GLP, and NY-DOH).

– Preferred experience with aseptic technique, RNA extraction, PCR, and robotic instruments.

– Quality Control experience.

Job Requirements: 
– The ideal candidate must have a bachelor's degree in medical technology, chemical, physical, or biological sciences and at least five (5) years of molecular and/or clinical laboratory experience.

– Must have significant QC experience in a regulated laboratory environment, preferably in a CAP=accredited clinical laboratory; quality certification preferred.

Shift and Salary: 
– Day Shift
– $90 – $115 (DOE)

About Us:
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 16 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.

Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com

#JY  Job #14425

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