Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the needs of those we serve. By being part of our team, you play a crucial role in maintaining this high standard and making a difference in the lives of patients.
What You Will Achieve
In this role, you will:
- 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 microbiological finished product laboratories stay 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.
- Conduct and review non-conformance investigations related to manufacturing and stability.
- Review and approval of data in Laboratory Information Management System for lot release.
Here Is What You Need (Minimum Requirements)
- Applicant must have a bachelor's degree with 3+ years OR a master's with 0+ years of experience.
- Demonstrated experience in manufacturing, quality, or engineering within the biotech or pharmaceutical industry
- Solid understanding of aseptic laboratory techniques and quality systems
- Ability to establish strong relationships within business lines
- Excellent written and verbal communication and interpersonal skills
- Proficiency in laboratory information management systems and data analysis software
- Strong problem-solving skills and attention to detail
- Experienced with analytical lab equipment (FTIR, Microscopes, etc.)
Bonus Points If You Have (Preferred Requirements)
- Experience in Quality Operations
- Familiarity with regulatory requirements and compliance standards
- Ability to work independently and as part of a team
- Strong organizational and time management skills
- Ability to adapt to changing priorities and work in a fast-paced environment
- Experience defending laboratory practices in regulatory audit.
- Working knowledge of organic chemistry, including degradation mechanisms of pharmaceutical active ingredients and pharmaceutical products
- Use of microscopes (i.e Scanning Electron Microscope), Raman Technology (i.e. Hound) and/or FTIRs
- Particulate/Particle Identification expertise
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
Schedule is 1st shift, Monday - Friday. Must be able to work on weekend, off shifts and holiday as business demands. Travel
Work Location Assignment: On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: May 21st, 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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What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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