What are the responsibilities and job description for the Quality Control Analyst II - Bio Chemistry position at Takeda?
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Job Description:
About The Role
As the Quality Control Analyst II - Bio Chemistry, you will focus on the daily lab operations and execution of testing to support manufacturing operations. Testing may include samples from drug substance and drug product, manufacturing, stability, raw materials and various protocol studies using test methods. The assays range from pH, enzyme concentration to more complex assays such as SDS silver Gels, PCR, and enzyme activity. You will maintain operational and GMP readiness of the QC areas and participate in more complex projects, operational excellence projects and quality systems.
You will report to the Quality Control Supervisor.
How you will contribute
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
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
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.S. Base Salary Range :
$67,900.00 - $106,700.00
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.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. 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. U.S. 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.
Locations:
USA - MA - Lexington - BIO OPS
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
Job Exempt:
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Job Description:
About The Role
As the Quality Control Analyst II - Bio Chemistry, you will focus on the daily lab operations and execution of testing to support manufacturing operations. Testing may include samples from drug substance and drug product, manufacturing, stability, raw materials and various protocol studies using test methods. The assays range from pH, enzyme concentration to more complex assays such as SDS silver Gels, PCR, and enzyme activity. You will maintain operational and GMP readiness of the QC areas and participate in more complex projects, operational excellence projects and quality systems.
You will report to the Quality Control Supervisor.
How you will contribute
- Testing execution of A280, SOLO A280, Compendial methods (pH. Moisture, OSMO, Appearance, Subvisible particles), Enzyme Activity assays, PCR, Free Thiol.
- Data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab house keeping, support for other QC groups.
- Compliance and quality systems (SOP revisions, input to quality system records).
- Bachelors degree and minimum of 2 years of experience of QC testing.
- MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and proven science understanding.
- Comprehensive Healthcare Medical, Dental, and Vision
- Financial Planning & Stability 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
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
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- 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.
- Limited to no travel expected.
- Repetitive bending and reaching to setup and break down equipment
- Walk and stand for periods of time
- Individual may be required to participate in an environment chamber monitoring program which would include the use of an on- call mobile phone as well as on site support during non-business hours
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
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.S. Base Salary Range :
$67,900.00 - $106,700.00
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.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. 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. U.S. 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.
Locations:
USA - MA - Lexington - BIO OPS
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
Job Exempt:
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Salary : $67,900 - $106,700
