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Quality Operations Laboratory Team Leader (3rd Shift)

Company: Pfizer Inc.
Location: Kalamazoo
Posted on: September 8, 2019

Job Description:

ROLE SUMMARY
This position will oversee the 3rd shift Rapid Turn Quality Operations Laboratory in Kalamazoo MI. The Rapid Turn Laboratory performs: Liquid Chromatography, Gas chromatography, Ion Chromatography, pH, LOD, titrations, Karl Fischer, UV/VIS, and multiple other analytical technologies used to determine quality attributes for Kalamazoo manufactured APIs and in-process samples. Leads the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the laboratory and department. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and oversees colleague development. Provides oversight of department during the 3rd shift, ensuring proper use of assets, budget, and personnel.

ROLE RESPONSIBILITIES
--- Review and approve cGMP documentation to assure compliance with regulatory requirements
--- Assess deviation impacts and resolve to prevent future occurrences.
--- Review and approve cGMP Changes in accordance with regulatory requirements
--- Review and approve training to assure cGMP requirements are met
--- Manage resources (people and assets) to meet work team goals
--- Support a continuous improvement culture where individuals can thrive in change
--- Thoroughly evaluate lab investigations, deviations, and associated corrective/preventive actions to ensure they are handled appropriately and documented effectively as they relate to the testing of raw materials, in-process samples, and final products.

BASIC QUALIFICATIONS

  • BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and minimum of 4 years of related experience or Associate's Degree in a Scientific discipline with a minimum of 10 years of related experience.
  • Previous experience with leading colleagues and/or projects is required.
  • The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
  • The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.
    PREFERRED QUALIFICATIONS
    • The candidate should have experience in multiple of the following areas: cGMP, Regulatory (world wide), deviation investigations,
    • Final API and/or drug product lot release, analytical method transfer/validation, process validation, laboratory testing, laboratory investigations, and batch record review.
      PHYSICAL/MENTAL REQUIREMENTS
      Laboratory and office work requiring walking, standing, and sitting throughout a shift. The job has minimal lifting, but may have extensive sitting and walking time. The ability to concentrate for long periods of time is necessary.

      NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
      The job is primarily third shift, however, there will occasionally be mandatory meetings for which attendance is required during first or second shift times. All Laboratory colleagues adhere to safe work practices such as wearing appropriate personal protective equipment including lab coat, safety glasses, and gloves. There is no routine travel associated with this position.

      ORGANIZATIONAL RELATIONSHIPS
      The role works and communicates often with peer Laboratory Management and Production Operator customers, and supports staff in all areas.

      RESOURCES MANAGED
      The annual unit budget is approximately 1.5 million dollars.

      Supervision
      The typical number of direct reports for this position is 10-15 individual contributor colleagues.

      Sunshine Act
      Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

      EEO & Employment Eligibility
      Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

      • Last Date to Apply: September 5th, 2019
      • Eligible for Employee Referral Bonus
        N (Other) (United States of America)
        Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Keywords: Pfizer Inc., Kalamazoo , Quality Operations Laboratory Team Leader (3rd Shift), Hospitality & Tourism , Kalamazoo, Michigan

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