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Quality Control Senior Associate Scientist

Company

Pfizer
Address , Sanford
Employment type FULL_TIME
Salary
Expires 2023-12-14
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 assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.
Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.
As a Senior Associate scientist, your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team. Your skill and knowledge will help in making decisions that require choosing among limited options. 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
  • Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
  • Serve as the responsible person writing investigations for QC Micro
  • Serve as the second shift Lead, supporting Junior Analysts with troubleshooting/issues
  • Initiate investigations
  • Perform 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.
  • Responsible for contributing to and/or handle laboratory investigations for events and Out of Specification results.
  • Perform laboratory support functions and maintain work area in a neat and orderly manner.
  • Assessing existing situations and suggesting improvements to increase compliance and innovation.
  • Perform tasks associated with maintaining current Good Manufacturing Practices compliant Quality Control and Stability laboratories.
  • Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
  • Responsible for appropriate creation, review and approval of GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, etc.) and ensuring adherence to Pfizer standards, guidelines and values.
  • Performs tasks associated with maintaining GMP compliant Quality Control and Stability laboratories. Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
  • Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.
  • Perform data review including updating weekly metrics for ensuring QC Micro is on track for batch release
  • Train junior colleagues and develop training plans and oversee training activities for groups.
  • Write Standard Operating Procedures, technical reports, project plans and other documents independently.
  • Responsible person for CAPA for QC Micro
  • 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.
  • Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.)
  • Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
  • May initiate and develop project plans to ensure projects timely completion.
  • May perform data trending activities and assist with metrics reporting.
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 degree with at least 3 years of experience OR Master's degree with more than 1 year of experience.
Nice-to-Have
  • Ability to establish relationships within business lines
  • Experience in Quality Operations
  • Understanding of aseptic laboratory techniques and quality systems
  • Overall collaborative nature
  • Understanding of laboratory practices and microbiological testing: i.e. LAL (endotoxin), Bioburden, Sterility, Growth Promotion, Organism Identification, media preparation, aseptic technique.
  • Excellent effective written and verbal communication and interpersonal skills
  • Knowledge in LIMS, QTS, SAP, eQMS, MODA, etc.
  • Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA

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 with priority covering weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.

Relocation support available
Work Location Assignment: On Premise

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