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Sr. Supervisor - Quality Assur...

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Job Summary

Company
Pfizer
Location
Brentwood, NY
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4903_4694693

Sr. Supervisor - Quality Assurance (Brentwood, 2nd Shift)

About the Job

Directs and leads Quality Oversight of  aseptic clean and prep, formulation, filling  and QA disposition activities at the Brentwood campus for St. Louis Operations.  In support of site wide objectives, supervises floor support activities, reviews and may be delegated to approve area documents such as Batch Records, Environmental Compliance records, SOPs, deviation investigations, validation protocols and reports, CAPAs and Change Requests.  Quality support with a focus on microbial and particulate control in support of aseptic production activities programs involving microbial control in production areas – cleaning and sanitation, disinfectants, training programs, etc.

Coordinates quality support of validation related activity and production preparation and operation.  Engaged with cross functional teams as needed to support continuous improvement activities.  Requires decision making ability related to Incident Investigation initiation, with emphasis on overall quality, site priorities, results and achievements.

ROLE RESPONSIBILITIES

  • Implement and execute procedures to assure compliance
  • with regulatory requirements and internal policies.
  • Provide feedback as requested to continuously improve technical training effectiveness and efficiency. Implements appropriate and aligned solutions as directed.
  • Supports operational excellence and site transformational initiatives.
  • Support for processes to hire, develop, coach, reward and monitor training and communication staff members.
  • Set and implement objectives and development plans for direct staff.
  • Work with site leadership to develop site specific messaging including site objectives.
  • Support communication process improvements throughout the site and enable replication of good practices between Pfizer sites.
  • Support production of site-wide meetings and special events and visits.

QUALIFICATIONS

  • Minimum of a Bachelor of Science Degree in Microbiology, Biology, Chemistry or related Technical Physical Science.  Masters Degree in related discipline preferred.
  • Minimum of three years progressive experience in GMP Pharmaceutical Manufacturing environment.
  • Minimum of previous team leader/supervisory experience.

Technical Skills Required

  • Knowledgeable of current cGMP Manufacturing standards.
  • Knowledge of regulatory compliance requirements for Pharmaceutical/Biological manufacturing (FDA,  EU) preferred.
  • Excellent oral and written communication skills, tailored to the audience or recipient of the communication.  Prefer presentation skills adequate to the immediate Quality team and Production team.
  • Demonstrated track record of organizational skills and attention to details.
  • Strategic thinking at a department level.
  • Ability to translate complex issues and accomplishments into language and messaging of general interest.
  • Passion for support of an engaged and change-agile culture.
  • Commitment to quality and customer service.
  • Excellent computer skills including experience with Word, Outlook, PowerPoint, Excel.

PHYSICAL/MENTAL REQUIREMENTS

Position requires ability to sit and or stand for extended periods and to work in a variety of settings including office areas, production, warehouse, and  some occasional time spent in clean room classification zones.  Additionally, the ability to drive between the local St. Louis sites is necessary (approx. 11 miles apart).  Ability to travel (limited basis).

Training presentations may be required to be delivered on primary shift for this role, 3rd Shift.

Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls.  Note that these activities may not be time bound to core hours or presence at the site.

Must have the ability  to work effectively under and manage to strict production, time and performance deadlines.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.

Must be able to gown aseptically and be able to audit the aseptic areas regularly.

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. 

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.

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: July 31, 2018
  • Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

 

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