Lab Technician: GMP/CLIA Testing & Quality Impact

Takeda Pharmaceutical Company Limited.

Hoover (AL)

Vor Ort

USD 53.870.000 - 84.702.000

Vollzeit

Vor 10 Tagen
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Benefits dieser Stelle

401(k) plan
Company match
Disability insurance
Life insurance
Tuition reimbursement
Volunteer time off
Company holidays
Paid vacation
Sick time
Well-being benefits

Zusammenfassung

Takeda Pharmaceutical Company Limited is seeking a Laboratory Technician in Hoover, AL, to perform high- and moderate-complexity testing under SOPs, GMPs, CLIA, and Takeda policies. You will manage samples, run tests, ensure accuracy, report results, maintain equipment, and document activities under the Laboratory Supervisor.

The role requires a biomedical degree with strong attention to detail, data integrity, and communication skills.

Qualifikationen

  • Required: Bachelor’s degree from an accredited college or university in a biomedical discipline, such as chemical, physical, biological, clinical laboratory science, or medical technology.
  • Ability to read, follow, and apply SOPs and maintain complete and accurate records.
  • Strong attention to detail and commitment to quality, compliance, and data integrity.
  • Excellent written and verbal communication skills, interpersonal skills, and analytical/problem-solving skills.
  • Proficiency using personal computers and applicable software.
  • Ability to determine potential impact to product quality when testing deviations occur, contain the situation, and support preventive actions.

Aufgaben

  • Perform authorized high and moderate complexity laboratory testing in alignment with education, training, certification, and technical ability.
  • Support sample management, test performance, quality control, result review, result reporting, and equipment maintenance to ensure accurate and timely testing.
  • Follow established procedures for specimen handling and processing, test analyses, reporting, and recordkeeping of donor test results.
  • Test proficiency samples in the same manner as donor samples and maintain required records.
  • Adhere to laboratory quality control policies and document quality control activities, instrument calibrations, procedural calibrations, and maintenance.
  • Identify issues that may impact test performance or result reporting; correct issues when appropriate or immediately notify laboratory management.
  • Follow corrective action policies and document actions taken when test systems deviate from established performance specifications.
  • Participate in operational excellence and continuous improvement initiatives, including 5S, Value Stream Mapping, and Kaizen.
  • Perform other duties as assigned.

Kenntnisse

SOP compliance
Attention to detail
Data integrity
Communication skills
Analytical thinking
Computer skills
Deviation assessment

Ausbildung

Bachelor’s degree in biomedical
Bachelor’s degree in medical technology
ASCP MT/MLT certification

Jobbeschreibung

Takeda Pharmaceutical Company Limited is seeking a Laboratory Technician in Hoover, AL, to perform high- and moderate-complexity testing under SOPs, GMPs, CLIA, and Takeda policies. You will manage samples, run tests, ensure accuracy, report results, maintain equipment, and document activities under the Laboratory Supervisor.

The role requires a biomedical degree with strong attention to detail, data integrity, and communication skills.

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