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SalaryWhy 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 and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the Quality Assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.
As a Senior Associate, 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.
Senior Quality Assurance Compliance Specialist will be responsible for ensuring that site standards, policies and procedures are aligned with global Pfizer Quality Standards and regulatory agency’s guidance’s and are operating in a state of compliance. Ensure that Rochester remains in an inspection readiness state by conducting internal site systems audits, monitoring compliance/quality performance indicator metrics, performing gap assessments, and addressing any areas of non-compliance. Assists in quality areas such as Site Internal Audits, Product Complaints, and Annual Product Reviews.
In this role, 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.
How You Will Achieve It
- Assures GMP audit is performed or on audit plan, as applicable
- Conducts department investigations
- Communicates critical issues to Senior Management
- Tracks CAPAs from investigations or audits
- Attend and present supplier metrics and monthly/quarterly Quality metrics at the Site Quality Review Team Meeting.
- Author and Revise various quality documentation (SOPs, CAS Reports, Change Controls, CAPAs/Commitments, Risk Assessments, Annual Product Reviews, Supplier Management, etc.)
- Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
- Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
- Contribute to the completion of projects, manage own time to meet agreed target dates and develop plans for work activities on own projects within a team.
Qualifications
- Applicant must have High School diploma with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience in scientific discipline preferred.
- Prior experience in a GMP quality team environment strongly preferred. The candidate must have demonstrated proficiency in organizational skills, balance multiple priorities, aptitude for technical learning, and problem solving.
- Strong verbal and written communication including presentation skills.
- Has strong technical experience and computer skills with quality systems (change control, deviations, SAP, documentation management, audits, inspections, etc.).
- Demonstrated ability to manage multiple projects and tasks at once.
PHYSICAL/MENTAL REQUIREMENTS
- Must be able to lift a minimum of 30lbs
- The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Must not have a Penicillin allergy.
- Minimal travel for training/seminars.
Last date to apply: Feb 15, 2024
The annual base salary for this position ranges from $78,000.00 to $130,000.00. 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.
