Manufacturing QA Associate 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 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 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
- Perform QA role to support cGMP production and testing operations
- Provide QA in plant support for manufacturing operations
- Review executed batch production records to ensure compliance with approved procedures and cGMP expectations. Communicate and resolve discrepancies
- Review/Approve Direct Material (i.e., raw material, other) testing to ensure data accuracy, conformance to specifications and documentation standards. Disposition and status label materials post disposition.
- Work with internal cross functional teams to resolve issues and identify corrective actions
- Review and Approve deviations, CAPA, and change controls. Monitor responsible open quality system records to closure
- Review cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet cGMP and internal standards
- Write and review Standard Operating Procedures as needed
- Bachelors Degree with 0+years of experience OR associates degree with 4 years of experience OR High School Diploma (or Equivalent) and 6 years of relevant experience
- Knowledge of cGMP and applicable FDA/international regulations
- Direct experience with plant operations, pharmaceutical/biotechnology manufacturing and analytical testing a plus
- Experience working with clinical and/or commercial products
- Detail oriented team player with effective planning, organization, and execution skills
- Excellent communication skills with internal and external personnel essential
- Ability to work effectively at a fast pace with cross functional departments
- Ability to anticipate and mitigate challenges
- Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems
- Experience at a manufacturing site
- Experience of writing and managing deviations
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
- Ability to lift up to 25 pounds and gown into manufacturing plant
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to work a 4/10 schedule (Wed-Sat or Sun-Wed)
- Ability to work weekends, evenings, holidays or overtime, as needed
- Ability to travel from North Creek to other sties in Bothell, WA
Other Job Details:
- Last day to apply: February 23, 2024
- Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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.