Quality Control Analyst I
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
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Job Summary/Operations Involvement:
Primary Duties of this position will focus on the daily lab operations and execution of reagent preparation and/or testing to support manufacturing operations /validation/ or development studies. Testing may include but not limited to samples from drug substance and drug product, manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities including stability pulls. This position is expected to maintain operational and GMP readiness of the QC areas. In addition, the individual may participate in more complex projects, operational excellence initiatives, maintenance of critical reagent inventory such as antibodies and cell banks, and various quality systems with supervision.
- Discretion/Latitude: Work is closely supervised. Follows specific, detailed instructions .
- Impact: Contributions are usually limited to task-related activities. Errors do not typically have a major effect on the organization.
Specific Cell biology Focus Areas:
Product Testing: Area focuses on techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing.
Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected. Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
- 50-60% of time Testing execution, Reagent Preparation Support
- 30-40% of time: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
Education and Experience Requirements
- Typically requires a bachelor’s degree and a minimum of 1-3 years of related experience. (science related degree is preferred)
Additional Specific Experience:
- Excellent communication, interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
Key Skills, Abilities, and Competencies
- Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.
- Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
Complexity and Problem Solving
- Solve routine problems of limited scope and complexity following established policies and procedures.
- Works on problems of limited scope.
- Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Builds stable working relationships internally.
Internal and External Contacts
- Contacts are primarily with immediate supervisor, and other personnel in the section or group.
- Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering
Other Job Requirements
- Limited to no travel expected. Travel between sites is required.
The following physical abilities are required in order to fulfill the job duties:
- Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
- Ability to work around chemicals (if working around the laboratories)
- Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
- Ability to walk and stand for periods of time
- Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
LocationsUSA - MA - Lexington - BIO OPS
Time TypeFull time
Job ID R0030786