Quality Control Specialist - Microbiology

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Job Description

About the role:

Plan and Develop improvement and compliance projects relating to the QC Microbiology department. Responsible for basic project management and documentation authoring (e.g. change controls, protocols, reports, and regulatory submissions). Provide technical knowledge and support investigation teams for QC Microbiology related systems and test methods. Self-led individual that works under only very general management. You will report to the Head of Quality Control Labs

How you will contribute:

• Lead projects across all shifts for the QC Microbiology department, including indirect management of assigned personnel when supporting these activities.
• Communicate with departments and influence decision-making to support QC Microbiology departmental priorities and projects.
• Develop project plans, change controls, protocols, final reports, revise procedures, and manage documentation for the QC Microbiology department.
• Review global documents for local compliance and assess gaps within the QC Microbiology department.
• Maintain and compile QC Microbiology metrics, including trend reports (e.g., environmental monitoring).
• Perform gap assessments for compliance with global standards and regulatory requirements.
• Manage QC Microbiology SOPs to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards while driving procedural improvements.
• Apply statistical techniques and maintain working knowledge of relevant CFR, USP, and other regulatory requirements.
• Use LIMS, MODA, or equivalent systems for test result entry, approval and tracking.
• Represent the lab in team settings for operational, project, or investigational activities to improve efficiency, cost savings, quality, and new product support.
• Maintain the area in GMP compliance while following EHS and Lean principles such as 5S.
• Ensure training compliance, maintain updated training records, and train staff for project requirements.
• Dispose of hazardous waste as applicable.
• Proficient in lab application software
• Provide technical, operational, and general GMP guidance to other lab personnel
• Provide subject matter expertise on the technical aspects of QC Microbiology.
• Help with laboratory audit ready status efforts in understanding FDA, Takeda, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.
• Understand and apply cGMP/DPD, follow CTP/SOPs, and meet EHS requirements
• Must be proficient in written and oral English.

What you bring to Takeda:

• Requires bachelor's degree in science, engineering, or other related technical field. Bachelor's degree in microbiology or Biological Science.
• Minimum 2 years of experience

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. You may:

• Must be able to lift, push, pull and carry up to 25 lbs.
• 20/20 near vision required (corrected as acceptable)
• Will need to recognize and distinguish among the colors red, yellow, and blue.
• In general, your work will be a combination of sedentary work, standing work, and walking around observing conditions in the facility
• Will work in controlled environments requiring special gowning. Will 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 make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• May work multiple shifts, including weekends.
• May work in a confined area.
• Some Clean Room and cool/hot storage conditions.
• Will work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Can work supplemental hours to complete work commitments.
• Inside working conditions.
• 5% travel as applicable.

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. 

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U.S. Base Salary Range:

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