QC Scientist

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 microbiology testing, particulate identification, and bioanalytical assay and methods 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.
QC Scientist has a deep knowledge in the discipline, to be an active team member who influences at the project team level. QC Scientist will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. QC Scientist ability to plan will help in preparing short-term work activities on projects. QC Scientist creativity in developing novel processes and new ideas will be used frequently. QC Scientist will undertake mentoring activities to guide your team members.
How You Will Achieve It

• Contribute to achievement of goals at the work group/ project team level as a full team participant.
• Perform tasks associated with maintaining {Current} Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
• Represent Quality Control Analytical in cross functional and site product meetings.
• Interpret data and make recommendations and reach decisions based on data and management input.
• Apply existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency, or devise and develop new microbiological Reporting issues to management and participating in issue resolution.
• Train junior colleagues, develop training plans and oversee training activities for groups.
• Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the environmental monitoring program is compliant with all regulatory requirements.
• Support change controls, investigations and other technical documents.
• Participate in regulatory filing writing in sections related to analytical method and stability testing.
• Determine environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities.
• Conduct and review non-conformance investigations related to aseptic manufacturing.
• Review and approval of environmental monitoring data and approval of data in Laboratory Information Management System for lot release.

Qualifications
Must-Have

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Demonstrated experience in industrial and/or aseptic pharmaceutical production environment, technical knowledge of aseptic processing and sanitization
• Demonstrated independent accomplishment of complex analytical method development and validation
• Ability to receive feedback and takes accountability for actions and personal development
• Excellent effective written and verbal communication and interpersonal skills
• Basic computer skills, such as data entry, with a high level of attention to detail, are also required

Nice-to-Have

• Pharmaceutical manufacturing experience
• Experience leading continuous improvement projects
• Experience defending laboratory practices in regulatory audit.
• Working knowledge of organic chemistry, including degradation mechanisms of pharmaceutical active ingredients and pharmaceutical products

PHYSICAL/MENTAL REQUIREMENTS
Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to work on weekend, off shifts and holiday as business demands. Travel 10%.
Work Location Assignment: On Premise
OTHER JOB DETAILS

• Last Date to Apply for Job: March 3, 2025
• Referral Bonus Eligibility: YES
• Eligible for Relocation Package: NO

The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% 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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