The Quality Coordinator is 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. The Quality Coordinator 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.
Identify 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.
Participate 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.
Education & Experience Requirements
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
Key Skills and Competencies
Takeda has maintained an unwavering dedication to put patients first for more than 235 years while we live our values of Takeda-ism-Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
We focus our research and development on the core therapeutic areas of oncology, gastroenterology, neuroscience, and on providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
BioLife, a subsidiary of Takeda, is an industry leader in operating high quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone. BioLife's employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.
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.
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.
Complexity and Problem Solving
Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.
Internal and External Contacts
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
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda's Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.