Responsible for the operation 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.
Performs quality assurance activities of BioLife Testing laboratory by performing the following duties.
Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to cGMP requirements to ensure that quality assurance standards and regulatory requirements are met prior to release from the Quality Assurance Department.
Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system processes in order to effectively perform laboratory quality assurance functions.
Adheres to the laboratory quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
Identifies problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the laboratory management.
Follow established corrective action policies and procedures whenever test systems are not within established acceptable levels of performance.
Document all corrective actions taken when test systems deviate from established performance specifications.
Performs review and or validation of SOPs as needed.
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.
Other duties as assigned.
Technical/Functional (Line) Expertise
Strong knowledge and understanding of applicable regulatory and quality requirements and standards.
Strong written, verbal, personal interaction and communication skills required.
Must be able to write concisely and clearly.
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.
Result oriented with 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.
Interfaces with employees of various educational backgrounds and levels within the company. Must be able to communicate effectively with all these various business partners.
Ability to stand up for 6-8 hours
Ability to lift, carry and pull up to twenty-five (25) pounds
Walking, standing, observing others performing work assignments.
Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.
Ability to work in an office / production environment.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.
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,)
Associate degree from an accredited college/university in laboratory science or medical laboratory technology.
Minimum of two years’ experience in a professional or technical capacity in laboratory services, blood services, quality, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
Technical/Professional certification preferred.
Prior experience with auditing and/or inspection processes preferred.
MT or MLT certification from ASCP or other accredited certifying organization preferred
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.