Responsible for the support of the laboratory in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable Takeda and BioLife policies, procedures and quality initiatives.Â
Plans and directs support activities of BioLife Testing Laboratory, (BTL-US) and may serve as CLIA General Supervisor, by performing the following duties personally or through subordinate supervisors.
Manages the day-to-day supervision of Laboratory Support Services.
Directly supervises Sample Logistics Supervisor, Facility Supervisor, Laboratory Office, Administrative personnel and other support staff.
Must be accessible to support personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems inÂ accordance with policies and procedures established either by the laboratory director or technical supervisor.
Provide daily supervision of result release performance by qualified testing personnel.
Monitors test analyses to ensure that acceptable levels of analytic performance are maintained.
Interviews, hires, and supervises performance of laboratory staff under the oversight of CLIA Laboratory Director and/or Technical Supervisor.
Ensures that proper training is received and documented under the oversight of CLIA Laboratory Director and/or Technical Supervisor.
Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality standards, efficiency, and schedules are met.
Oversees release of test data to Quality Assurance for batch release.
Provides technical assistance to staff, operations, and donor centers in laboratory related issues.
Organizes and prioritizes workloads and assignments in conjunction with donor center requirements.
Participates in evaluation of new equipment and methodologies.
Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance.
Advises Director of Operations, Quality Assurance Manager and technical personnel of laboratory support activities.
Works in conjunction with Laboratory Quality Assurance Manager in the implementation, monitoring, and maintenance of the laboratory quality systems.
Performs periodic review of SOPs and changes are implemented in a timely manner.
Ensures all procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines.Â SOP manuals contain current versions of procedures and manufacturer inserts.
Participates in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals (including but not limited to 5S, Value Stream Mapping and Kaizen.
All other duties as assigned.
The following are duties that may be designated by CLIA Director and Technical Supervisor to Laboratory Services Manager:
Assure that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
Ensure that test results are not reported until all corrective actions have been taken and the test system is properly functioning.
Provide orientation to area personnel.
Annually evaluate and document the performance of testing and support personnel.
Technical/Functional (Line) Expertise
Excellent interpersonal skills and communication skills including written, verbal and oral presentations.
Attention to detail and organizational skills with analytical and problem solving skills.
Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
Ability to adapt to changing priorities.
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.
Interacts with employees of various educational backgrounds and levels within the company.Â Must be able to communicate effectively with all these various business partners.
Walking, standing, observing others performing work assignments.Â
Office / Production environment.
Occupational exposure to blood borne pathogens.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor's degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology,) and at least 5 years of laboratory training or experience in high complexity testing,
Associate's degree in a laboratory science or medical laboratory technology, and at least 7 years of laboratory training or experience in high complexity testing.
Bachelor's degree or higher from an accredited college/university in medical technology.
MT/MLT Certification Preferred
Five to seven years of
Familiarity with regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment.
3-5 years management experience required.
FLSA Classification (US) â Exempt
USA - GA - Social Circle - Baxter Pkwy
Internal Number: R0035181
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.