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 help Pfizer in quality assurance of its clinical and commercial batches of drugs produced. Your planning skills will help us evaluate and review batch records, batch disposition and maintain related documentation. You will leverage on your sampling and statistical process control skills, in order to identify deviations from established standards, in the manufacturing and packaging of goods. In the relevant cases, you will further review and approve investigations and change control activities to ensure compliance with configuration management policies.
You are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will train others and reinforce behaviors that will help us achieve our goal of providing the best to patients.
How You Will Achieve It
- Manage own time, professional development and accountable for own results.
- Prioritize own workflow and allocate work of others and assist in establishing their priorities.
- Responsible for providing input for performance assessment on team members.
- Track the implementation of the identified actions within agreed timeframes.
- Provide support for the equipment calibration and maintenance program.
- Coordinate the needed corrective action with affected business units.
- Ability to understand data in support of investigational activities.
- Assist in the investigation of deviations to aid supervisory personnel and management in undertaking corrective actions or recommendations.
- Assist in writing and updating standard operating procedures as related to microbiology and pharmacology data review.
- Provide ongoing education on Quality to relevant functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.
- Perform, document, record check, and troubleshoot qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation.
- Review B.E.T. sterility, potency assays, environmental and limit testing on all products.
- Notify all applicable supervisors and attend regular QC (Quality Control) meetings.
- Works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze drug product samples via various analytical methods in support of the company's quality program in the chemistry laboratory.
- Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms.
- Oversee quality operations at contractors.
- Maintain a clean and organized laboratory environment.
Qualifications
Must-Have
- High School Diploma or GED
- 6+ years’ experience
- Certification in assigned area, if applicable
- Successful hands-on analytical testing experience in a Good Manufacturing Practices {also cGMP} environment
- Demonstrated proficiency in applicable computer software and systems
- Demonstrated personal leadership and accountability in day-to-day interactions with an operational regard for customer needs and process requirements
- Must have strong organizational skills and an ability to multi-task across projects and activities
- Good communication skills for written reports
- Basic computer skills in Microsoft Office
Nice-to-Have
- Applicable experience in quality functions of pharmaceuticals industry
- Proficiency in using the Quality Tracking System Laboratory Information Management System Application & Products and Lot Review Tracking systems
PHYSICAL/MENTAL REQUIREMENTS
Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Day Shift: Fri - Mon (8am - 4:30pm)
- Individual will be expected to work nonstandard schedule as needed to support the business objectives
- Relocation support might be available for certain cases
Work Location Assignment: On Premise
Last Date to Apply: November 30th, 2023
The salary for this position ranges from $30.02 to $50.03 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. 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 applies only to the United States - North Carolina - Rocky Mount location.
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.
Quality Assurance and Control
#LI-PFE
"An Equal Opportunity Employer M/F/D/V"
