13 days old

Quality Control Microbiology Supervisor

Baxalta U.S., Inc.
Thousand Oaks, CA 91362
  • Job Code
    R0036254

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Control Microbiology Supervisorin our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Supervise, plan, organize, direct, and evaluate routine activities of Quality Laboratory to ensure the safety and reliability of Takeda products and to comply with quality and regulatory requirements. Support and make critical decisions for the release of raw materials, in-process production, and final release of finished products in a timely manner. Identify potential risks associated with laboratory operations and lead teams to resolve quality issues. Implement testing standards and policies. Manage daily operation of the lab and control of workflow to ensure operational efficiency with emphasis on results and continuous improvement. Coach lab personnel and enhance their performance. Evaluate employee performance on a regular basis.

Essential Duties and Responsibilities

  • Ensure completion of all testing, including raw materials, in-process, stability, and special project/protocol testing in a timely manner that achieves fulfillment to commitments
  • Implement and continuously improve quality systems to ensure compliance with testing SOPs and specifications. Utilize regulatory and quality guidelines such as FDA, GLP, QSR, cGMP, USP, and CDR as guidance for these systems
  • Monitor testing techniques and review accuracy of records and documentation generated
  • Lead and/or support problem-solving sessions through application of the problem-solving tools and methods to coordinate and/or lead investigation teams
  • Perform routine walkthroughs and compliance checks to verify adherence to quality guidelines. Interact with inspectors in regulatory audits to represent area of responsibility
  • Lead 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
  • Proactively lead initiatives to contribute to build a strong team and increase efficiency, solve problems, resolve issues, generate cost savings, and improve quality
  • Adhere to established expenditure controls to support management of laboratory budget
  • Ensure a safe and accountable working environment for employees by adhering to company work rules, policies, and safety standards
  • Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback. Ensure employees have development plans. Create performance improvement plans (PIP) where necessary
  • Ensure employees are properly trained and/or qualified and periodically audited. Ensure personal training requirements are met and that training records are current
  • Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPSs, and other appropriate documentation for proper function of the lab operation
  • Ensure equipment maintenance and calibration is robust and completed on time
  • Work with minimal Supervision to set clear direction for all direct reports consistent with departmental needs
  • Drive Lean principles such as 5S throughout daily work activities
  • Other duties as assigned by departmental management

Qualifications

  • Current understanding of pharmaceutical industry regulations and trends in the regulatory environment, specifically Microbiology related regulations.
  • Knowledge of operating and troubleshooting methods for lab equipment as well as quality and regulatory requirements pertinent to quality control of pharmaceutical and biological quality labs
  • Must demonstrate ability to apply sound scientific principles and compliance standards to laboratory testing requirements as performed in pharmaceutical quality control laboratories
  • Must demonstrate good Supervisory skills and excellent interpersonal skills for effective communication with subordinates, peers, and management
  • Effective at handling and resolving personal conflicts in a proactive manner
  • Good leadership, organizational, and time-management skills demonstrating the ability to manage multiple projects and/or lab operations concurrently and effectively. Must be able to manage complex scenarios and continue to meet business commitments on time
  • Must demonstrate the ability to effectively coach, mentor, and motivate direct reports, resulting in a high-performing team with a focus on results and task completion in support of operational goals
  • Must demonstrate effectiveness in holding direct reports accountable for assigned tasks, work rules, and safety standards through a combination of positive and constructive reinforcement
  • General knowledge of statistical techniques. Working knowledge of QSR, cGMP, CFR, USP, and GDP
  • Demonstrate good technical writing skills (e.g. exception reports, laboratory investigation reports, deviations) and the ability to seek and identify robust, mistake-proofing solutions
  • Represent the laboratory through technical presentations, material review board, management reviews, and other department presentations
  • Computer literate and competent with a solid knowledge of word processing and spreadsheets (such as Microsoft Office). Must be capable of preparing formal presentations
  • General working knowledge of laboratory application software
  • Knowledge of applying QLP problem-solving methods
  • Demonstration of basic project management skills

Education and/or Experience

  • Typically requires a bachelor's degree in chemistry, biological science, or another related technical field. 5+ years of related experience. Some leadership experience preferred

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 make-up, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in the manufacturing environment
  • In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility

Work Environment

  • Requires shift, weekend, and holiday work.
  • May be required to travel for business reasons, e.g., training and meetings.
  • Must be able to work in a controlled/clean room environment requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No makeup, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in these work environments.
  • Must be able to work more than 8 hours a day or 40 hours a workweek, as required.
  • Will have interactions with other people.
  • Pace may be fast and job completion demands may be high.
  • Will work around chemicals such as alcohol, acids, buffers, and celite that may require respiratory protection
  • Must be able to work supplemental hours as necessary to complete work commitments.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

This job posting exclude Colorado applicants

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Sponsored by:
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Quality Control Microbiology Supervisor

Baxalta U.S., Inc.
Thousand Oaks, CA 91362

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