QA Specialist, Change Management

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's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's 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

• Responsible for the review, coordination and implementation of Pfizer and PC1 changes that impact the McPherson plant.
  
• Provide consulting support to business units, corporate, and customers for changes.
  
• Act as the McPherson site resource for change plans which impact the plant, including ensuring product is held and equipment is not used, until qualified and found acceptable.
  
• Track, trend, and report changes that apply to product, procedures, processes, equipment, facility changes, and all affected systems.
  
• Quality reviews and approves changes to ensure they are executed per site change management procedure.
  
  
• Qualifications
  

Must-Have

• Applicant must have a High School Diploma and 6 years of relevant experience; OR an associate degree with 4 years of experience; OR a bachelor's degree with 0-2 years of experience.
  
• Prior experience in quality, laboratory, manufacturing, validation and/or engineering
  
• Highly organized
  
• Experience working as a cross-functional environment
  
• Practical experience in quality, production and/or production systems in a GMP regulated environment
  
• Excellent verbal, writing and interpersonal communication skills
  
• Proficient computer skills in Microsoft (MS) Word, Excel and PowerPoint required. Experience with electronic quality systems preferred.
  

Nice-to-Have

• Experience with using change management systems, i.e. QTS or similar software
  
• Experience across Combination Product, Medical Device, Aseptic manufacturing
  
  

PHYSICAL/MENTAL REQUIREMENTS

• Evaluating and reviewing electronic documents
  
• Office environment with some production floor interaction (minimal)
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• This role is standard days Monday through Friday work shift.
  
• Must be able to support 24/7 manufacturing site; some off-shift hours may be required.
  

Other Job Details:

• Work Location Assignment:Flexible
  
• Eligible for Relocation Assistance: NO
  

PHYSICAL/MENTAL REQUIREMENTS

Evaluating and reviewing electronic documents

Office environment with some production floor interaction (minimal)

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Be able to support 24/7 manufacturing site

Work Location Assignment:Flexible

The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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'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.

Quality Assurance and Control

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