QA Specialist III

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 operations or laboratory support, 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 support QA activities related to operations or testing laboratories.

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 manufacturing or the testing laboratories. You will approve investigations and change control activities to ensure compliance with policies and current Good Manufacturing Practices (cGMPs).

As a QA Specialist III, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus 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 projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Suggest improvements and conduct continuous improvement activities.
• Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices impacts.
• Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
• Maintain regulatory compliance in accordance with cGMPs.
• Provide Quality Review and oversight of site cGXP documentation related to the support of Quality Control Laboratories and Site Operations to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
• Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
• Review and approval of documents.
• Participation in audits and inspections as required.

Qualifications

Must-Have

• Bachelor's Degree required
• 5 – 7+ years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required.
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
• Excellent communication and interpersonal skills

Nice-to-Have

• Biology, Chemistry, Engineering, or related Technical Physical Science field of study preferred
• Previous experience in QA strongly preferred
• Previous experience in QC, Manufacturing and/or Engineering preferred
• Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), SAP and Pfizer document repositories
• Experience with quality aspects of start-up of a manufacturing facility is helpful but not required

Physical/Mental Requirements

• Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.  

Non-Standard Work Schedule, Travel, or Environment Requirements

• Position is first shift Monday through Friday.  Some occasional off hour (night/weekend/holiday) support may be required to support staff and operations.

Other Job Details:

• Eligible for Relocation Assistance: YES

#LI-PFE 

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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