Posted in General Business 13 days ago.
Location: Lexington, Massachusetts
Primary duty of this position is operational support for the QC GMP functions, both for cross-functional teams as well as for core laboratory operations support.
Minimal supervision. Work may be done without established procedures.
Errors are very difficult to detect and would normally require significant expenditures to resolve.
Specific QC Focus Areas:
Area focuses on sample receipt/login/inspection, sample and retain management, QC records archival and control, coordination of materials for external shipping, aliquoting of samples, stability study initiation and time point pulls, and supporting laboratory operations, including buffer and reagent preparation.
Responsibilities: Job Function and Description
Operational support activities such as reagent and buffer preparation, chamber maintenance including sanitization, sample management, records management, QC area housekeeping activities and lab support duties, data review, shipments to CMOs/CTLs, and stability pulls
Sample handling activities including product complaint evaluations, reference standard and assay control aliquoting and inventory maintenance, reserve and retention sample annual inspections
Coordination with other departments to facilitate support activities and/or leading on non- routine projects within the department, involvement on cross-functional projects
Education and Experience Requirements
Key Skills, Abilities, and Competencies
MS Office, LIMS, TrackWise, EDMS
Complexity and Problem Solving
Works on assignments that are complex in nature where judgment is required in resolving problems and making routine recommendations. Applies job skills and company's policies and procedures to complete a wide range of difficult tasks.
Internal and External Contacts
Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation from individual.
Other Job Requirements
Travel between MA Bio Ops sites may be required.
The following physical abilities are required in order to fulfill the job duties:
If individual is to be trained to execute certain test method where visual evaluation is required, the individual maybe required to take a medical examination for vision and color blindness (as required by the specific test in question).
This job posting excludes Co Applicants
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.
Beacon Hill Staffing Group