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Job Description

About the role:

As a Quality Control Analyst - Biochemistry, you will conduct biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw material through finished goods including at a minimum; in-process, final container, stability and critical systems testing.Responsible for ensuring the daily operations of assigned functional area are met through scheduling, troubleshooting, and coaching.Must participate and/or support completion of improvement projects and responsible tasks.

How you will contribute:

• Conduct biological, chemical and physical analyses on raw materials, stability, in-process samples and final products, and samples collected from systems monitoring programs, following controlled test procedures.  Work under Supervision.

• Use laboratory instrumentation and computer systems to collect and record data. 

• Perform assays requiring precise analytical skills and understanding of biological and chemical principles.

• Perform reviews of test data with the application of GDP.

• Complete all testing, including special project / protocol testing in a timely manner. 

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR and cGMP regulations.  Ensure data integrity and regulatory compliance is maintained in assigned area and/or system.

• Demonstrate familiarity with product specifications, CFR, manufacturing processes, and compendia requirements.

• Use Global LIMS or other computerized systems for entering and approving test results. 

• Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

• Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines.  Will be expected to do laboratory walk through to ensure area is suitable for hand off to oncoming shifts.

• Perform equipment maintenance and calibrations as required.  May be the subject matter expert on assigned equipment.

• Apply Lean principles such as 5S throughout daily work activities.

• Ensure personal training requirements are met and that training records are current. 

• May be required to perform microbial testing (e.g. environmental monitoring water collection, etc) as qualified and applicable to support the Manufacturing Facility.

• May perform removal of hazardous waste.

• Other duties as assigned by departmental management.

What you bring to Takeda:

• Requires a Bachelor’s Degree in science-Chemistry or Biological Science is preferred. 2+ years of experience.

• Must be proficient in written and oral English.

• Ability to manage multiple tasks concurrently and complete tasks in a timely manner.

• Must be detail oriented, conscientious and responsible.

• Must have basic understanding of laboratory instrumentation and chemical handling.

• Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.

• Effective interpersonal communication skills.  Must have effective verbal and written communication skills. 

• Proficient with lab application software and able to learn new computer systems and programs in a timely manner. 

• Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).

• Capable of applying relevant CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs and applicable USP, JP, EP procedures.

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:

• 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.

• Must be able to lift, push, pull and carry up to 25 lbs.

• 20/20 near vision required (corrected as acceptable).

• Must be able to recognize and distinguish among the colors red, yellow, and blue.

• Must be able to work in controlled environments requiring special gowning.   Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.  This may include additional hearing protection for loud areas.

• No contact lenses may be worn in the work environment.  No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.

• In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.

• May be required to enter a cold, wet environment and climb stairs or ladders to retrieve samples.

• Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.

• May be required to work or be assigned to a different shift to meet business needs.  Must be willing to work off shift hours.

• Must be able to work overtime as required.

• May be required to work in a confined area.

• Primarily inside working conditions.

• Some clean room and cool/hot storage conditions.

• 5% travel as applicable.

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

Takeda Compensation and Benefits Summary

For Location:

U.S. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 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.

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Job Exempt