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Job Description

About the role:

Retains responsibility across functional areas to monitor and recommend actions to reduce bioburden and other potential contamination within all production environments.Position is responsible for results in terms of product quality and conformance to regulations and Takeda quality policies.

How you will contribute:

Responsibilities

• Support development and deployment of the site Contamination Control Strategy in alignment with regulatory  and company expectations
• Assists in troubleshooting and solving bioburden issues within the facility by applying critical problem-solving tools to improve negative trends.
• Interacts and influences practices in the facility in order to improve GMP compliance relative to contamination control.
• Supports continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Supports implementation and improvement of quality systems to ensure compliance with testing SOPs and specification.  Utilize regulatory and quality guidelines such as FDA, GLP, QSR, cGMP, USP, and CDR as guidance for these systems.
• Perform routine walk throughs and compliance checks to verify adherence to quality guidelines. 
• Prepare, review and revise, as required, SOPs and specifications.  Write memos, reports, protocols, CPAs and other appropriate documentation to support investigation and routine manufacturing as appropriate. 
• Understands and assures conformance to regulations in a section or department.  Interface with non-regulatory and regulatory inspectors during inspections.
• Other duties as assigned by departmental management may include: performs a wide range of biological analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. Position is applicable to  Microbiological testing.

What you bring to Takeda:

Education and Experience Requirements

Typically requires bachelor's degree in biological science, or other related technical field. Some related work experience preferred.  Relevant experience in cGMP related industry, including 2+ years in Quality, Sterility Assurance, Contamination Control preferred

Important Skills, Abilities, and Competencies

• Knowledge of standard microbiological procedures (EM, bioburden,  bacterial endotoxin testing)
• Experience in aseptic technique, clean-room behavior and practice, cleaning methodologies, and risk assessments
• Demonstrate good technical writing skills. Able to write effective technical documents.
• Demonstrate the ability to seek and identify robust, mistake-proofing solutions. Strong analytical and problem-solving skills.
• Demonstrate effectiveness in ability to train others, encourage empowerment, and drive completion of project and/or milestone commitments.
• Proficient in wet and instrumental methods of analyses.
• Advanced laboratory skills and basic knowledge of statistical method.
• Strong technical problem-solving skills
• Ability to handle multiple tasks concurrently, and in a timely fashion.
• Must communicate effectively (verbal and written) with supervisors and peers.
• Knowledge of most laboratory equipment including but not limited to autoclaves, incubators and analytical equipment.
• Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Knowledge of basic chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word, Excel and PowerPoint.

Complexity and Problem Solving

• Will support complex investigations (such as Medium or High Level CAPAs).
• Able to follow directions.
• Able to identify when proper practices/ procedures are not performed.
• Follow SOPs and generate results.

Internal and External Contacts

Role interacts with numerous organizations throughout the facility, including Manufacturing, Quality, Maintenance, Engineering, and contractors utilized throughout the site. 

Position may act as a support function to manufacturing operations and is required to routinely coordinate testing activities and communication of results with IG, Fractionation, and Albumin. In addition, the individual will also correspond with other support functions such as QA, Engineering, Maintenance, etc. Position may be required to participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.

Other Job Requirements

• PHYSICAL DEMAND

• Must be able to lift, push, pull and carry up to 25 lbs.
• 20/20 near vision required (corrected vision is 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.

• WORKING ENVIRONMENT

• 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 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 supplemental hours as necessary to complete work commitments.
• May be required to work in a confined area.
• Inside working conditions.
• Some clean room and cool/hot storage conditions.
• In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.

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

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:

• 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.

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.

This posting excludes Colorado applicants.

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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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