Sr. Associate - QA Operations

Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
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
In your role, you have the all-important task of providing Quality Assurance oversight to GMP manufacturing and testing operations for clinical drug substance, intermediates, and starting materials. This includes quality oversight of technology transfer and disposition deliverables such as review of batch records, investigations, CAPAs, SOPs, test methods, change controls, and release of drug substance, intermediates, and starting materials (e.g. cell banks). Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.
As a Sr. 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 important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your dedication and hard work that will make it possible for Pfizer's customers and patients to receive the medicines they need, when they need them.
How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
• Review and/or approve various GMP documents, primarily batch records and investigations and including procedures, change controls, validation qualifications, and CAPAs.
• Perform quality assurance disposition function for raw materials, in-process solutions, and/or production batches.
• Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
• Participate on technology transfer teams reviewing and approving master batch records and related documentation.
• Support the site relative to a constant state of inspection readiness.
• Participate in audits relative to this role as needed.
• Make quality decisions to resolve moderately complex issues with minimal assistance from management.
• Recognize when an issue is beyond their sphere of influence and escalate immediately.
• Present to peers/management locally or electronically.
• Contribute to quality assurance management team initiatives and objectives.
• Provide review of equipment/instrument validation documentation and related calibration documentation, as needed.
• Participate on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance.
• Participate in quality risk management activities.
• Assist in the process of gathering, interpreting and applying statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations.
• Assist in the review of area documentation and perform trend analysis on data, controls and standards.
• Responsible for knowing, understanding and acting in accordance with Pfizer's values.
• Demonstrate strong interpersonal, teamwork, and collaboration skills.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree 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
• Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
• Understanding of cGMP, Data Integrity.
• Strong understanding of Quality System functions, manufacturing and/or packaging processes
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Experience in preparing and participating in audits and inspections

Bonus Points If You Have (Preferred Requirements)

• ALCOA principles
• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Experience in mentoring and training colleagues

PHYSICAL/MENTAL REQUIREMENTS
Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus, communication 1:1 and with larger groups). Ability to independently problem solve and make recommendations for solutions. Role is primarily office-sitting, standing, walking, and bending. This may be inclusive of leading/participating in video conferences.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
None - limited travel, if any.
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.
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Quality Assurance and Control