QC ANALYST II

Job Description Job Title.
QC Analyst II Location.
Lexington, MA About the role.
As a QC Analyst II, you will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies which includes Testing but not limited to samples from drug substance and drug product manufacturing, stability and several protocol studies using approved test methods or test methods derived from QC technical protocols.
You will maintain operational and GMP readiness of the QC areas and maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities.
You will report to the Quality Control Supervisor.
How you will contribute.
Receive assignments in the form of goals and establishes goals to meet objectives.
Work is reviewed and measured based on meeting goals and schedules.
Establish and recommend changes to policies which effect subordinate organizations.
May support sampling activities.
Also, you will participate in more complex projects, operational excellence programs, and several quality systems with general guidance.
Exert some influence on the goals.
Product Testing.
Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., to support in-process, release and stability testing.
Support commercial and clinical testing for defined site-based and external programs, and method transfer and validation.
Introduce new equipment and technology to improve sustainability and compliance.
Additionally, you will provide support for Quality projects and implementation of operational excellence programs.
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Testing execution, participate in training analysts, trouble shooting of methods.
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QC operations support which requires data review, data trending, OE/5S/LEAN programs, maintenance of equipment and reagents, lab house keeping, support for other QC groups.
Compliance and quality systems (SOP revisions, input to quality systems records).
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Involvement in multiple departmental and cross-functional teams and programs; inspection and regulatory support.
Develop solutions to a variety of complex problems.
May refer to established precedents and policies.
Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Demonstrate judgment in selecting methods and techniques for obtaining solutions.
Networks with senior internal and external personnel in own area of expertise.
Contacts external to QC may include.
Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory, Manufacturing, Facilities and Engineering.
What you bring to Takeda.
Typically requires a bachelor's degree and a minimum of 5+ years of related experience.
(science related degree would be ideal).
Previous experience in a GMP QC role would be ideal.
Complete understanding and application principles, concepts and practices.
Full knowledge of industry practices.
Experience with MS Office, LIMS, SAP, Trackwise, compliance and science understanding.
Limited to no travel expected.
Travel between sites is required.
Important Considerations At Takeda, our patients rely on us to deliver quality products.
As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.
In this role, you may.
May be required to wear personal protective equipment (PPE) and other clean room garments daily.
This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
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.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1 #LI-Onsite Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career.
We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location.
USA - MA - Lexington - BIO OPS U.
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Base Salary Range.
$ The estimated salary range reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
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based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s.
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based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
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based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement 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.