Senior Quality Control Analyst - Cell Therapy
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Senior Quality Control Analyst - Cell TherapyApply Now
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Quality Control Analyst, Cell Therapy in our Cambridge Cell Therapy Manufacturing site.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a QA Manager Validation Cell Therapy working on the R&D Quality team, you will be empowered to support the Facilities, Equipment and Validation Lifecycle. This position is 100% onsite and ensures compliance with applicable regulatory and Takeda specific guidance for GMP pharmaceutical operations in support of internal manufacturing of clinical-phase cell therapies
- The Senior QC Analyst Cell Therapy is responsible for the performance of testing of cell therapy investigational medicinal products (IMP) utilized in Takeda clinical studies.
- This position is responsible for sample management, shipment of samples to Contract Laboratories and tracking and trending sampling data.
- This position is responsible to assist in activities for the QC and EM laboratory and all related qualification activities such as participating in environmental monitoring performance qualifications and method transfer and verifications and validations.
- Perform incoming component/raw material inspection/testing, in-process testing, and product release testing to support the manufacturing of cell therapy drug products manufactured in the internal GMP facility.
- Responsible for sample management and sending samples to Contract Laboratories. Ensure open communication to Contract Laboratories to ensure turnaround times are met.
- Responsible for reserve/retention sample and reference sample management.
- Responsible for data trending and report writing as assigned.
- Assist in testing, managing, data trending and report writing related to stability as needed.
- Assist in stability testing as needed.
- Assist in environmental monitoring of cleanroom as needed.
- Assist in environmental monitoring performance qualifications and method transfer and verifications and validations as needed.
- Author, edit, and review SOPs, job aids, reports etc. as assigned.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Assist in the investigation into any non-conformance, OOS, OOT, instrument malfunction, accident or other abnormal occurrence per SOPs.
- Assist in maintenance, calibration and cleaning of QC equipment and instruments as needed.
- Assist in diverse qualification activities (facility, cleaning, software etc.) as needed.
- Assist in the Microbiology laboratory as needed.
- Keep the QC lab clean, safe and tidy all the times.
- Work closely and collaboratively with cross-functional team members from QA, QC, production, facility and development.
- Additional duties as assigned.
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise
- Working knowledge of Good Manufacturing Practice requirements.
- Strong analytical knowledge and practical technical experience with cell therapy methods such as flow cytometry (FACS), q-PCR, cell count methods, and ELISA is a must
- Experience in raw material sampling and testing
- Experience writing specifications
- Experience writing and reviewing SOPs for QC laboratories
- Experience using a LIMS is a plus
- Excellent organizational, communication, and interpersonal skills
Decision-making and Autonomy
- Ability to follow written and verbal directions, as well as carry out testing and tasks independently
- Experience working in a laboratory
- Demonstrated ability to collaborate with others
- Ability to read, analyze and interpret common scientific and technical documents/information
- Effectively presents information to management, internal groups and stakeholders.
- Ability to adapt to changing priorities
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s Degree in Biology or another relevant field
- Minimum of 5 years’ experience in the bio/pharmaceutical industry
- Minimum of 3 years’ experience in GMP QC laboratory
This posting excludes Colorado applicants.
Time TypeFull time
Job ID R0033180