Quality Operations HHDP Laboratory Manager/TL
Kalamazoo, MI 
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Posted 18 days ago
Job Description

This position will oversee a portion of the Human Health Drug Product Laboratory in Kalamazoo MI.  The Human Health Drug Product Laboratory performs: Liquid Chromatography, Gas chromatography, pH, LOD, titrations, Karl Fischer, UV/VIS, Sub-Visible Particulate Testing, IR and multiple other analytical technologies used to determine quality attributes for Kalamazoo manufactured Drug Products.  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, 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 organizational goals

• Perform GAP assessments for new & revised PQS

• Ensure timely validation of new & transferred methods

• Support a continuous improvement culture where individuals can thrive in change

• Ensure appropriate metrics are in place to monitor progress against business objectives and achieve the desired results.

• 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.

• Track and trend analytical data to ensure laboratory is producing quality results and all instrumentation and systems are functioning properly

 

BASIC QUALIFICATIONS

BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and minimum of 7 years of related experience. Previous experience with supervision of colleagues or significant 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 at least several of the following: cGMP, Regulatory (worldwide), 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 role is a first shift role.  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. 

 

 

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.

 

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.

 

  • Last Date to Apply for Job: 11/26/2018
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus

 

Job Summary
Company
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
7+ years
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