Quality Operations Laboratory Team Leader (3rd Shift)
Company: Pfizer Inc.
Posted on: September 8, 2019
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.
--- Review and approve cGMP documentation to assure compliance with
--- Assess deviation impacts and resolve to prevent future
--- Review and approve cGMP Changes in accordance with regulatory
--- Review and approve training to assure cGMP requirements are
--- Manage resources (people and assets) to meet work team
--- 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
- 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
- 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.
- The candidate should have experience in multiple of the
following areas: cGMP, Regulatory (world wide), deviation
- Final API and/or drug product lot release, analytical method
transfer/validation, process validation, laboratory testing,
laboratory investigations, and batch record review.
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.
The role works and communicates often with peer Laboratory
Management and Production Operator customers, and supports staff in
The annual unit budget is approximately 1.5 million dollars.
The typical number of direct reports for this position is 10-15
individual contributor colleagues.
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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