Why Patients Need YouEverything 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 AchieveYou 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.How You Will Achieve ItSupport the Pfizer North Sanford, NC Quality Assurance Compliance and Inspection depart by performing Quality Assurance activities associated with clinical, commercial, and/or contract production.Interprets current Good Practices (cGxP) regulations / guidelines and Pfizer Quality Standards to ensure that the site remains compliant within these requirements. Ensures compliance through the site self-assessment program (SSA) by conducting internal system audits and walkthrough audits, ensuring placement and approval of audit corrective / preventive actions, assisting with Inspection Readiness activities, and suggesting / implementing continuous improvement activities.
Plan and perform Site Self Assessments through internal system and walkthrough audits, write reports, and follow-up on responses and corrective / preventive actions.
Assist site departments with improvement projects as they relate to inspection readiness and as identified during Site Self Assessments.
Provide guidance / coaching during audits and CAPA planning.
Remain up to date on current Regulatory trends (Regulatory Observations, New Regulations / Guidelines) as well as Pfizer Quality Standards.
Assist with supplier / vendor audits as needed.
Support and prepare site for audits and regulatory inspections.
Perform other Quality Compliance functions as needed.
Decision making regarding adequacy and accuracy of documentation and systems to meet regulatory requirements and timely elevation of noted errors, inconsistencies or deficiencies to appropriate management.
Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls.
Knowledge of US, EU, and ROW cGxP regulations, Microsoft Office applications, specifically Word and PowerPoint, Lean Six Sigma concepts: and Quality Risk Management.
Experience with Laboratory information Management System (LIMS), Global quality Tracking System (TrackWise application), Systems, Applications, and Products (SAP) and Document Management System (PDOCS).
A broad depth of knowledge of cGxPs (including Good Manufacturing Practices, Good Laboratory Practices, Good Documentation Practices and Good Clinical Practices).
Provides guidance/coaching during audits and CAPA planning.
Provides guidance/coaching to less experienced colleagues.
Resolves complex issues with minimal assistance from management.
Makes sound decisions that may involve complex quality and technical issues.
Shared Accountabilities: Collaboration with a wide range of co-workers, customers, and management to gather the input and background knowledge needed to complete assignments.
QualificationsMust-Have
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree with 6 years of experience OR a Bachelor's with at least 3 years of experience OR Masters with more than 1 year of experience.
Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls required.
Knowledge of US, EU, and ROW cGxP regulations
Experience in lab or manufacturing procedures and quality control and validation.
Nice-to-Have
Relevant work experience in a manufacturing environment, preferably in compliance.
Experience in internal and external audits.
ASQ certification a plus
Physical/Mental Requirements:
Position requirements are typical for an office- lab work environment with some shop floor exposure.
Must be able to wear required PPE:safety glasses, lab coat, safety shoes, nitrile gloves, area gowning.
Occasionally perform mathematical calculations and ability to perform complex data analysis.
Non-Standard Work Schedule, Travel, or Environment Requirements:
This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise.
Ability to travel (both domestic and international) up to 10%.
Other Job Details:
Last day to Apply: March 29th , 2024
Eligible for Relocation Assistance: NO
Work Location Assignment:On Premise
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 ActPfizer 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 EligibilityPfizer 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
