Location
Rocky Mount, NC | United States
Job description
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 be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.
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. You will be responsible for validating/qualifying the systems used to manufacture drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products. The area of responsibility will be the Equipment/Facility/Utility Qualifications (IQ, OQ, PQ) and requalification's in the Sterilization, Formulation and Commodity Preparation business unit areas.
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 - 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.
- Provide high level data analysis support for Quality Investigations.
- Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
- Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.
- Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
- Coordinates and communicates all testing with affected functional groups and evaluates test results.
- Executes equipment validation studies to include protocol preparation, scheduling, execution, including data analyze data and generation of summary reports.
- Assess potential impact of changes to qualified systems; Identify and implement validation best practices to continuously improve the site validation program.
- Participates in presentation of results to Regulatory Agency, when necessary.
- Support regulatory audits through the preparation, defense and interaction with auditors in areas related to sterilization, commodity prep and formulation equipment .
- Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
- Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
- May supervise and/or mentor junior level engineers.
- Ensure integration of validation schedule in production schedule for implementation of validation activities and ensure due dates and customer needs are met.
Qualifications Must-Have - Applicant must have High School Diploma (or Equivalent) 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.
- Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and {Current} Good Manufacturing Practices {part of GxP}.
- Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices.
- Must be proactive, have experience with high performance teams, strong interpersonal and project management skills.
- Must be able to interact with varying levels within the company.
- Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
- Strong conflict resolution skills.
- Must be able to work multiple shifts as needed to meet deadlines.
Nice-to-Have - Relevant pharmaceutical experience.
- Familiarity with information systems, such as Global Document Management System, System Application & Products and Quality Tracking System.
- Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices.
Non-Standard Work Schedule, Travel, or Environment Requirements - Work Location Assignment:On Premise.
Other job details - Last day to apply: March 25, 2024.
- Relocation support available: Yes.
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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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