Posted in Other 30+ days ago.
Type: Full Time
Responsible for performing testing 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.
* PERFORM ONLY HIGH AND MODERATE COMPLEXITY TESTS FOR WHICH CERTIFICATION HAS BEEN AUTHORIZED BY THE LABORATORY DIRECTOR OR DESIGNEE AND DEEMED COMMENSURATE WITH THEIR EDUCATION, TRAINING, AND TECHNICAL ABILITIES.
* Responsible for sample management, test performance, quality control, result review, result reporting and equipment maintenance such that accurate and appropriate sample testing is performed, completed, and reported in a timely manner.
* Follow the laboratory s procedures for specimen handling and processing, test analyses, reporting and maintaining records of donor test results.
* Test and maintain records that demonstrate proficiency testing samples are tested in the same manner as donor samples.
* Adhere to the laboratory s 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 the laboratory s established corrective action policies and procedures whenever test systems are not within the laboratory s established acceptable levels of performance.
* Document all corrective actions taken when test systems deviate from the laboratories established performance specifications.
* 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.
TECHNICAL/FUNCTIONAL (LINE) EXPERTISE
* Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records
* Excellent written and verbal communication skills, interpersonal skills and analytical/problem solving skills
* Proficiency in the use of personal computers and applicable software
* 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
* Potential exposure to blood borne pathogens requires 90% of work tasks to be performed while wearing gloves
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelor degree 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
Bachelor degree in medical technology or Associates degree in medical laboratory technology
1 year laboratory training or work experience preferred
MT or MLT certification from ASCP or other accredited certifying organization preferred
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.