QA Analyst

About the role:

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 essential systems testing. Ensure the daily operations of assigned functional area are met through scheduling, troubleshooting, and coaching. Must participate and guide completion of improvement projects and responsible milestones. You will report to the Supervisor of the Quality Lab.

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 some Supervision.

• Use laboratory instrumentation and computer systems to collect and record data. May perform advanced assays requiring an understanding of biological and chemical principles.

• Perform review of test data with application of GDP.

• Complete all testing, including special project / protocol testing. Prepare and direct lab protocol studies under some guidance.

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

• Demonstrate familiarity with product specifications, process reference files, code of federal regulations, and compendia requirements.

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

• Contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency,, produce cost savings, improve quality, and provide new product support.

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

• Prepare and update SOPs under guidance.

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

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

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

• May be asked to perform microbial and particulate monitoring of clean rooms throughout the Manufacturing Facility for qualification purposes.

• May perform removal of hazardous waste.

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

What you bring to Takeda:

• Typically requires bachelor’s degree in chemistry, biological science, or other related technical field. Some related work experience preferred.

• 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.

What Takeda can offer you:

• 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

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.

Empowering our people to shine:

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.

Location and Salary Information: This post excludes CO applicants

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