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GENERAL SUMMARY OF POSITION: 

Under the direction of the Director of the NENSP, the QA/QC Manager serves as the manager of the New England Newborn Screening Program (NENSP) QA/QC, Privacy, and Safety programs, and works collaboratively with lab supervisors to ensure compliance with client commitments and state/federal regulations.

Assembles QA/QC (including CLIA), Privacy, and Safety regulations information applicable to the NENSP, and maintains NENSP files and records that document compliance with these regulations. University of Massachusetts staff relevant to QA/QC, Privacy, and Safety, and communicates as appropriate with NENSP staff.

Perform a variety of functions, within the New England Newborn Screening Program, to assure the overall quality of program operations.  Responsible for managing the ongoing development, implementation and maintenance of quality control systems and activities.  Oversee development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of laboratory results.  Make recommendations for corrective action necessary to assure conformity with quality specifications.  Assures organizational processes conform to government and University standards, and satisfies appropriate regulations.

MAJOR RESPONSIBILITIES:

Serves as the Laboratory QA/QC manager by conducting the following duties:

• Develops, maintains and strengthens knowledge and awareness of QA/QC, privacy and safety best practices.  Periodically meets with the Director for guidance on best practices and to ensure that programs and initiatives are on point with the strategic and tactical objectives of Newborn Screening.
• Represents NENSP with respect to QA/QC, privacy and safety by serving on Enterprise-wide committees (such as quality), coordinating efforts with appropriate UMMS staff.
• Gathers and disseminates QA/QC (including CLIA), Privacy, and Safety information to supervisors and staff to ensure staff-maintain desired certifications and receive adequate training as appropriate.
• Reviews and audits laboratory operations to assure compliance with standard operating procedures.  Collaborates with laboratory supervisors to recommend changes that will improve quality, and assesses effects of changes in progress.
• Reviews and audits all laboratory record keeping procedures; develops, presents and implements improvements as necessary.
• Centrally maintains all records for laboratory employee training and certification, incident reports, problem logs, proficiency surveys, and other records relevant to Program laboratory QA/QC and inspections. Assembles and submits QA/QC reports required for clients/contracts.
• Acts as point person for laboratory inspections by regulatory agencies and contracting agencies.
• Establishes and maintains systems for analyzing laboratory quality control data; prepares summary reports and recommendations based on findings.
• Attends monthly QA/QC meetings for all laboratory sections and keeps minutes of same.
• Oversees and maintains quality control and proficiency testing programs in accordance with CDC and CAP guidelines; maintains associated records for all laboratory areas.
• Oversees and maintains lab compliance with CLIA, NRC, and OSHA regulations; represents the NENSP at State Laboratory meetings on these topics.

Serves as a resource/consultant to laboratory supervisors:

• Supports Lab Supervisors in their creation and updating laboratory procedure manuals, and preparation of incident reports

Assists in the recruitment efforts and interviews of new laboratory personnel

Serves as the Program’s Safety Manager:

• In conjunction with UMMS Safety officials, assures that NENSP staff receive training opportunities in laboratory safety
• Maintains safety training records

Serves as the Program’s Privacy Manager:

• In conjunction with UMMS compliance officials, maintains and updates Program’s Privacy Policy
• Assures that NENSP staff are trained in the Program’s Privacy Policy
• Maintains records of privacy disclosures

Performs other additional job-related duties as required

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SPECIAL SKILLS AND COMPETENCIES:

Observable behaviors that are required by the person performing the position in order to meet expectations for the outputs)

• Excellent organizational skills.
• Proficiency in statistics
• The ability to establish and maintain good working relationships with all Newborn Screening personnel.

REQUIRED QUALIFICATIONS:

• Master’s degree in Biochemistry, Chemistry, Immunology, Medical Technology, or equivalent
  • OR Certification in medical technology, or equivalent level of experience
• 5 years technical experience in clinical laboratory
• 2 years’ experience involved with CLIA and OSHA compliance
• Ability to travel as required.

PREFERRED QUALIFICATIONS:

• Experience with Newborn Screening operations and protocols strongly preferred
• Proficiency with analytics (data base queries such as MS Access, Excel)
• Experience with validation of laboratory methods, instruments, and data systems
• Experience with Laboratory Information Management Systems (LIMS), especially Specimen Gate (a product of Perkin

Posting Disclaimer:
This job posting outlines the primary responsibilities and qualifications for the role but is not intended to be an exhaustive list. Duties and expectations may evolve in response to the needs of the department and the broader institution.

In alignment with our commitment to pay transparency, the base salary range for this position is listed above (exclusive of benefits and retirement). At UMass Chan Medical School, final base salary offers are determined based on a combination of factors, including your skills, education, and relevant experience. We also consider internal equity to ensure fair and consistent compensation across our teams.

Please note that the range provided reflects the full base salary range for this position. Offers are typically made within the midrange to allow for future growth and development within the role.

In addition to base pay, UMass Chan offers a comprehensive Total Rewards package, which includes paid time off, medical, dental, and vision coverage, and participation in a 401(a)-retirement plan, with the option to contribute to a voluntary 403(b) plan.

UMass Chan welcomes all qualified applicants and complies with all state and federal anti-discrimination laws.