Manager Product QC Lab

Job ID
2021-8420
Location
St Petersburg-Main
Department
Bio Product QC
Geographic Location
US-FL-St Petersburg
Category
Healthcare

Overview

Under the direction of a Director, manages the day-to-day activities and provides leadership and technical expertise for Product Quality Control and Platelet Manufacturing areas of the Biologics Department. Coordinates workflow for the areas, manages staff scheduling, training and competency and quality activities. Ensures that testing is completed in a timely and accurate manner in accordance with regulatory guidelines and organizational policies and procedures. Ensures efficiencies and productivity meeting established KPI for the areas.

Responsibilities

 

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position. If designated by the technical supervisor/director and appropriately licensed, may serve as the laboratory general supervisor. If not designated as the laboratory general supervisor, functions as a manager in an administrative capacity.

  • Manages the operations of assigned area ensuring efficiency of workflow, productivity, minimization of waste and continuity of services
  • Provides or obtains technical assistance for the daily operation of the laboratory
  • Ensures that standards for compliance, use of equipment, and quality control are met as required by organizational policies and all accrediting, state and/or federal agencies
  • Ensures completion of employee departmental orientation, competency testing, compliance training and other mandatory instruction
  • Evaluates, develops and implements new SOPs and protocols
  • Oversees occurrence reports, investigation of concerns and follow up, problem resolution, record keeping and reporting
  • Provides oversight of Assistants, Technicians and Technologists
  • Provides recommendations for technical changes and improvements in assigned area and participates with vendors and representatives to maintain equipment services and other contracts
  • Assists with implementation of new methodologies, test or functions
  • Participates in external and internal audits as required
  • Performs laboratory procedures, functions and other departmental duties as required
  • Monitors testing processes to identify errors or potential problems leading to errors and takes effective and preventive corrective actions when indicated
  • Monitors productivity and efficiencies of the department using spreadsheets and takes actions when indicated.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

 

EDUCATION AND/OR EXPERIENCE:

Bachelor's degree in medical technology, healthcare, chemistry, biology, biotechnology or related field from an accredited college or university. Five (5) or more years’ experience in a related field or an equivalent combination of education, certification, training, and/or experience.

 

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

Valid and current Florida Clinical Laboratory Technologist license required. Supervisor license in Immunohematology, Serology, Chemistry, Hematology and Microbiology, or Blood Banking required or eligible.

 

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of and ability to interpret and apply federal and state regulations as they relate to quality assurance and regulatory affairs
  • Ability to organize work for timely completion
  • Ability to follow complex oral and written instructions
  • Ability to communicate effectively orally and in writing
  • Ability to delegate, manage and supervise effectively
  • Ability to work with minimal supervisionAbility to establish and maintain effective and cooperative working relationships with those contacted in the course of work
  • Skill in operating office equipment
  • Word processing abilities, Excel, Power Point knowledge required
  • Ability to travel up to 50% of the time
  • Ability to commute with personal transportation

 PHYSICAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).

 

ENVIRONMENTAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

 

Functions are regularly performed inside and/or outside with potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances. Performance of this job could expose the employee to blood-borne pathogens. The noise level in the work environment is usually moderate.

 

OneBlood is an Equal Opportunity Employer/Vet/Disability/Other Protected Categories

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