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Quality Control Associate Scientist, Microbiology

Company

Pfizer
Address , Sanford
Employment type FULL_TIME
Salary
Expires 2023-10-16
Posted at 8 months ago
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 control team. You will be responsible for analyzing, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.
As an Associate scientist, your strong foundation in general scientific practice and in the principles and concepts of the discipline will help us achieve our goals. You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge.
It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
  • Apply existing techniques and procedures, with recommendations, and implement modifications for improved efficiency.
  • Responsible for appropriate creation of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
  • Operate within established HR policies and basic colleague relations guidelines.
  • Write Standard Operating Procedures (SOPs), technical reports, project plans etc. independently.
  • Perform tasks associated with maintaining Good Manufacturing Practices {also cGMP} compliant Quality Control and Stability laboratories.
  • Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.
  • Support product transfers/new product development, regulatory queries, cost improvement projects or Drug Product plant support for Cleaning Validation.
  • Responsible for reporting issues to management and participating in issue resolution (such as reporting Out of Specification (OOS) results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)
  • Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.
  • Responsible for knowing, understanding and acting in accordance with Pfizer’s values.
  • Act safely and follow Environment, Health and Safety requirements for site and QC laboratories.
  • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending.
  • Contribute to the completion of team objectives and assigned project milestones.
  • Performs testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and EM samples.
Qualifications
Must-Have
  • Knowledge of Microsoft Office applications, specifically Word and Excel
  • Fundamental understanding of laboratory instrumentation function and analytical method troubleshooting
  • Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an Associate's degree with 4 years of experience OR a Bachelors degree with 0-2 years of experience.
  • Excellent oral, written and interpersonal communication skills
Nice-to-Have
  • Knowledge of environmental monitoring during pharmaceutical manufacturing and an understanding of aseptic techniques
  • Experience with and in depth understanding of Microbiology testing (e.g. sterility, bioburden, viability, purity etc)
  • Experience defending laboratory practices in regulatory audits
  • Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
Physical/Mental Requirements
  • 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 complex mathematical problems and perform complex data analysis
Non-Standard Work Schedule, Travel, or Environment Requirements
  • Work schedule is an alternate shift primarily second shift, some off-shift support needed may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.
Other Job Details:
  • Work Location Assignment: On Premise
  • Last day to Apply: August 31st, 2023
  • Eligible for Relocation Assistance: NO
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
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