Manager, QC Microbiology

Employer
Takeda Pharmaceutical
Location
Thousand Oaks, California, US
Salary
Competitive
Closing date
Dec 1, 2021
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Job Description

Job Title: Manager, QC Microbiology
Location: Thousand Oaks, CA

About the role:

The Manager, QC Microbiology is an individual contributor role and will oversee and maintain EM (Environmental Monitoring) and Utilities monitoring and trending program. Assess impact of new regulations on current practices and drive projects to ensure alignment. Plan, develop, and lead improvement and compliance projects relating to the QC Microbiology department. Responsible for basic project management, alignment with Global procedures and documentation authoring (e.g. quality improvement plans, risk assessments, protocols, reports, regulatory submissions, etc). Provide technical knowledge and/or support investigation teams for QC Microbiology related systems, processes, procedures, and test methods. Self-led individual that works under only very general supervision to meet deadlines/goals.

How you will contribute:

  • Oversee Environmental and Utilities Monitoring and trending.
  • Support review of Global documents to ensure local compliance and evaluate gaps within the QC Microbiology department.
  • Assist in the development, establishment and monitoring of systems that focus on key indicators within the QC Microbiology department.
  • Be directly involved in and lead multiple process/product improvement projects. These projects may be executed through Deviations/CAPA, Belt Projects (Blue Belts / Green Belts), Kaizens, or other focus groups.
  • Lead cross-functional meetings to ensure projects are completed.
  • Lead projects across all shifts for the QC Microbiology department including indirect supervision of assigned personnel when supporting these activities.
  • Interface with other functional areas and influence decision making on behalf of the QC Microbiology department to support departmental priorities and projects.
  • Develop Project plans, change controls, generate protocols and final reports, revise local procedures, and manage other documentation to support the QC Microbiology department.
  • Provide subject matter expertise on the technical aspects of QC Microbiology.
  • Assist in 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.
  • Lead in the development of customer awareness and support activities for QC Microbiology, and assist and drive such activities throughout the shifts.
  • Operational liaison with various customers including Manufacturing, Quality Assurance and Manufacturing Services.
  • Support Continuous Improvements in the QC Microbiology department; Support initiatives such as the site CI Master Plan, 5S, Visual Controls, VIPs, Lean Labs, etc.
  • Demonstrated track record of managing multiple tasks and projects concurrently and driving projects to completion in a timely manner.
  • Excellent organizational skills and ability to plan and suggest resolutions to technical problems.
  • Proficient understanding of critical laboratory, manufacturing and facility processes.
  • Understand scientific strategies and be able to recommend different technical strategies and analyses during investigations.
  • Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office). Capable of performing advanced data analysis through various applications software (such as Minitab and Discoverant).
  • Excellent interpersonal communication and influencing/negotiation skills. Must have strong verbal and written communication skills.
  • Represent the laboratory through technical presentations, management reviews, and other department presentations. Must be comfortable presenting effective presentations to stakeholders and to site management.
  • Capable of applying decisions-making to problem-solve technical, compliance, or operational problems as assigned.
  • Must be able to understand and apply cGMP/GDP, follow SOPs, and meet EHS requirements.
  • Understanding of Data Integrity Principles is recommended.
  • General knowledge of statistical techniques. Working knowledge of CFR, USP, and other compendia requirements that affect the QC Microbiology department.
  • Proficient with wide variety lab application software.
  • May perform other duties as assigned.


What you bring to Takeda:

  • Bachelor's degree in chemistry, biological science, or another related technical field.
  • 5+ years of related experience


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:
  • Laboratory/Manufacturing environment.
  • Inside working conditions.
  • Must wear personal protective equipment due to safety requirements in designated lab areas. May be required to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in these work environments.
  • Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
  • May work around Methotrexate, which is a known cell growth inhibitor.
  • May require immunization before performing work within the manufacturing area.
  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.
  • Overtime may be required at times.
  • Will be required to work an alternate work schedule (10 hour shift / 4 days a week).
  • May be required to work or be assigned to a different shift as needed.
  • Maybe required to work weekends and holidays.
  • Will have interaction with other people.
  • Pace may be fast and job completion demands may be high.
  • May infrequently need to travel to other local Takeda sites in Southern California, as assigned.


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.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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