• Job Description

  Req#: 4894726

  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 and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs.

  The Sr Quality Control Associate will be responsible for performing multiple tasks within the Quality Control (QC) group in support of GMP large-molecule manufacturing activities. Focus areas include execution of analytical method qualification/validation protocols, routine analytical testing and documentation/data review of QC generated results. The position requires extensive experience within a QC setting and detailed knowledge of GMP/GDP. The Sr. associate will perform a variety of responsibilities in both a team and individual setting. This position is an on-site position based at the Sanford North facility in Sanford, NC.

  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

  • Demonstrates a working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, GC, FTIR, KF, etc.)

  • Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.

  • Leads the implementation of programs (e.g. evaluation/implementation of compendial testing).

  • Participate in/Support cross-functional projects and teams within the Pfizer network as a Subject Matter Expert (SME).

  • Leads laboratory investigations to determine root cause for OOS, OOT, Atypical and invalid test results.

  • Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.

  • Contributes to laboratory operations by performing regular instrument calibration and minor instrument maintenance.

  • Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.).

  • 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.

  • Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.

  • Provides review and approval of analytical test method qualification/validation protocols received from Analytical Technologies (AT) and external method development laboratories.

  • Leads the execution of qualification/validation protocols and writes technical reports in collaboration with Analytical Technologies (AT). Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

  • Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

  • Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.

  • Train colleagues and may develop training plans and/or oversee training activities for groups.

  Qualifications

  Must-Have

  • High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or other related discipline with 6 years of experience OR a Bachelor's degree in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or other related discipline with at least 3 years of experience OR Master's degree in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or other related discipline with more than 1 year of experience.

  • Experience working in a GMP laboratory setting.

  • Knowledge of compendia (USP, Ph. EUR, and JP) and ICH guidelines.

  • Strong written and oral communication skills, proficient with Microsoft Office software.

  • Knowledge of fundamental analytical chemistry principles (i.e. use of standards and controls, matrix effects, sample preparation, sample management, calculations, control charting, spectroscopy, chromatography, ELISA, and use of laboratory equipment, protein methods, etc.)

  • Demonstrates a working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, GC, FTIR, KF, etc.)

  • Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.

  • Leads laboratory investigations to determine root cause for OOS, OOT, Atypical and invalid test results.

  • Train colleagues and may develop training plans and/or oversee training activities for groups.

  Nice-to-Have

  • LIMS experience/knowledge of computer system hardware, infrastructure and networks is highly desired.

  • Control/Data trending using statistical tools.

  • Relevant pharmaceutical experience

  
  

  Physical / Mental requirements

  • Frequently lift and or move objects up to 30 pounds.

  • Stand/walk during entire length of shift.

  • Use of arms, hands and fingers to handle, feel or reach.

  • Ability to climb, balance, stoop, kneel, crouch, or crawl.

  • Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.

  Non-Standard work schedule, travel or environment requirements

  • Limited travel for the position; no more than 10% traveling for training purposes only.
  • Initially, it will be 4 days of 10 hours/day schedule (7am-5pm; Monday - Thursday). Occasional off shift days/hours and holiday worktime may be required as necessary for STATs once the laboratory is operational.
  • The schedule for this role could eventually changed to a 12-hour shift (7am - 7pm; Sun-Wed), rotating every other Wednesday eventually.

  Other job details

  • Last day to apply: October 16th, 2023

  • Employee Referral Bonus eligible

  
  Work Location Assignment: On Premise

  The annual base salary for this position ranges from $75,700.00 to $126,300.00. 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.

  Quality Assurance and Control

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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