Sr. QA Associate - Validation

Use Your Power for Purpose
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
As a Sr. QA Associate - Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pfizer Groton, CT site as well as provide remote support for our RCMF operation in Ringaskiddy Ireland.
This Operations Quality role within the Pharmaceutical Sciences Operations Quality (PSOQ) organization will offer the opportunity to collaborate with key business lines across the Pharmaceutical Sciences Small Molecule (PSSM) network in support of new technology and small molecule therapies.
In this role, you will:

• Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.).
• Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews.
• Support projects and contribute to validation strategy.
• Participate and support quality investigations including root cause analysis, Pfizer Human Performance assessments, and approval of investigation reports.
• Review and approve change controls, quality investigations, and corrective/preventive actions.
• Participate in the development of procedures which increase efficiency while maintaining high quality standards
• Provide support to internal audits (e.g. RQA) & regulatory inspections (e.g. FDA, HPRA) as needed.
• Support special projects, teams and global initiatives.

• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree in chemistry , Engineering, Biology, or other relevant STEM field is required, or equivalent relevant experience with at least 2 years of experience; OR a master's degree with 0+ years of experience.
  OR an associate's degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience
• Awareness of U.S. current Good Manufacturing Practices (GMP) and EU GMPs with respect to manufacturing and testing requirements for clinical supplies used in phase 1 through 4 clinical trials as demonstrated by work experience
• Strong critical thinking skills
• Ability to work effectively within own team and interdepartmental teams
• Proactive approach to problem-solving

Bonus Points If You Have (Preferred Requirements)

• Knowledge of cGMP's related to equipment and computer system validation/qualification.
• Knowledgeable of PharmSci GMP business line functions.
• Experience in quality investigation techniques
• Experience with Quality Risk Management (QRM)
• Previous quality assurance experience is preferred
• Hands-on knowledge of systems such as GDMS, eQMS, QTS, and EAMS.
• Experience with advanced data analytics/visualizations (e.g., Spotfire, Tableau, MS Power Business Intelligence)

PHYSICAL/MENTAL REQUIREMENTS
Not applicable.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This position may require infrequent travel to Pharm Sci sites in the PSSM network
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $80 300,00 to $133 900,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10,0% 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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
#LI-PFE