Change Control Specialist

Rochester, MI, United States

Job Description



Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve
You will be a member of Pfizer\xe2\x80\x99s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer\xe2\x80\x99s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Ensure that quality control procedures adequately evaluate an organization\'s products.
  • Coordinate with Pfizer Digital and central support team for enhancements, upgrades or issues in Quality Tracking System.
  • Review and approve documents as Quality representative, such as SOPs, Computer Systems validation or verification documentation, Change Controls, Investigations, Official Computer Systems Lists.
  • Responsible for change management program with changes involving and impacting facility, equipment, procedures, and products.
  • Complete impact assessments on requested site Change Requests to determine potential for quality impact.


Qualifications

Must-Have
  • High School Diploma (or Equivalent) and 6 years of relevant experience OR an associate degree with 4 years of experience OR a bachelor\'s degree with 2+ years of experience in change management
  • Familiarity with the use and functionality of Track wise and Vault
  • Ability to work as part of a team in a cross-site support model with colleagues of diverse backgrounds.
  • Makes decisions that requires choosing between limited options to resolve problems basic in their complexity.
  • Good communication skills, asks questions and checks for understanding.
  • Experience with Labware Laboratory Information Management System, Word, MS Excel, Quality Tracking System


Nice-to-Have
  • Demonstrated ability to learn and master new applications software.
  • Experience in conducting and documenting manufacturing incident or customer complaint investigations



PHYSICAL/MENTAL REQUIREMENTS
  • Able to lift 25-30 lbs
  • This is a penicillin manufacturing facility. Any candidates applying must NOT be allergic to penicillin.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Monday \xe2\x80\x93 Friday (i.e. 0700-0330 negotiable ) with occasional weekend work.

Work Location Assignment: On Premise
Last date to apply: October 18, 2023

Relocation assistance may be available based on business needs and/or eligibility.









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\xe2\x80\x99s 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.
Quality Assurance and Control
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Job Detail

  • Job Id
    JD4354882
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Rochester, MI, United States
  • Education
    Not mentioned