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
The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, stability and environmental monitoring. Key responsibilities are performing Good Manufacturing Practices (GMP) tasks/activities associated with maintaining compliant Quality Control and Stability laboratories; testing; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/Out of Specification (OOS) results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents Quality Control on cross functional teams; and leads projects and/or teams providing guidance/training/coaching to junior colleagues; assists in regulatory and internal audits.
This position is focused on Microbiological assays. Experience in bioburden, viable count method (serial dilution), media certification, sterility, microbial identification, and culture purity is preferred. Analyst would be a Senior Analyst responsible for ensuring routine testing is scheduled, completed, and reviewed within the required time frame. Analyst would be available for trouble shooting and to direct/coach junior analysts. Other responsibilities would include Standard Operating Procedure (SOP) revisions, qualification/validation support, as well as represent Quality Control (QC) Microbiology in meetings and during internal and regulatory audits. Analysts may be required to perform testing as needed for supporting lab functions. Your being proactive in team discussions will help in creating an environment of collaboration.
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 It
Responsible for knowing, understanding and acting in accordance with Pfizer’s values.
Performs tasks associated with maintaining current Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.
Extensive hands-on micro lab testing including but not limited to clinical and/or commercial product, raw materials and validation samples.
Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
Train and mentor junior colleagues on individual methods, method validations and help execute MV activities.
Write and/or review Standard Operating Procedures, technical reports, project plans and other documents independently.
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.
Good understanding of project management and method transfer for activities for clinical and commercial readiness.
Analyze and interpret results, makes decisions regarding accuracy, completeness and compliance.
Responsible for detailing requirements for Laboratory Information Management System (LIMS) builds, building, testing and managing its Master Data changes.
Able to holistically review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
Perform tasks associated with maintaining current Good Manufacturing Practices Compliant Quality Control and Stability laboratories.
Able to develop training plans and oversee training activities for groups.
Responsible for contributing to and/or handling laboratory investigations for events and Out of Specification results.
Responsible for CAPAs, Effectiveness checks, and commitments ownership.
Perform laboratory support functions and maintain work area in a neat and orderly manner.
Qualifications
Must-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.
- Demonstrated experience in industrial and/or aseptic pharmaceutical production environment, cGMP Laboratory, technical knowledge of aseptic processing and sanitization.
- Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
- Effective written and verbal communication and interpersonal skills
Nice-to-Have
- Experience in bioburden, viable count method (serial dilution), sterility, microbial identification, and culture purity is preferred.
- Knowledge of and experience with the following are preferred: US, EU, and ROW cGMP; pharmacopeias; ICH guidelines, analytical chemistry and/or Microbiology techniques and instrumentation.
- Experience in Investigations, Formal Quality Change Control or Quality Risk Management including risk assessments.
- Computer systems including Laboratory Information Management System (LIMS), Global Quality Tracking System (TrackWiseTM application); eQMS(Veeva), Microsoft Office™ applications.
- Project Management experience and Lean Six Sigma concepts.
Physical/Mental Requirements:
- Position requirements are typical for an office-lab work environment with some shop floor exposure.
- Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
- Intellectual capability to perform mathematical problems and perform data analysis.
- Demonstrated independent accomplishment of complex analytical method development and validation.
- Ability to receive feedback and takes accountability for actions and personal development.
- Ability to establish relationships within business lines.
Non-Standard Work Schedule, Travel, or Environment Requirements
- Work schedule will be weekends: Sunday-Wednesday: 4 days/40 hours
Other Job Details:
- Last day to Apply: April 12th, 2024
- Eligible for Relocation Assistance: YES
- 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 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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