Quality Compliance Specialist

Use Your Power for Purpose Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on members who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as you help bridge the gap between innovation and patient care. By being part of this team, you contribute to making life-saving treatments accessible, embodying the essence of our mission. What You Will Achieve The primary function of the Quality Compliance Specialist is to provide quality oversight in manufacturing areas by : Enforcing best aseptic practices/techniques within the Aseptic or Terminally Sterilized manufacturing areas per the Aseptic Observation Program Providing real-time quality oversight during aseptic process simulations. Providing real-time quality oversight following planned and unplanned activities. Providing GMP walk throughs ensuring regulatory compliance. Providing real-time quality oversight during environmental control deviations. How You Will Achieve It Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing. Provide support to aseptic process simulations (media fills), smoke studies, and hypercare for new aseptic processes when implemented. Provide quality oversight and approvals during the execution and recovery of planned and unplanned events (OARs, EDRs, Power Interruptions). Maintain a compliant state (Inspection Readiness Walkthroughs) Enforcing best aseptic practices/techniques within the Aseptic or Terminally Sterilized manufacturing areas per the Aseptic Observation Program Meet Aseptic Observation Program Monthly/Annual required metrics Drive continuous improvement through implementation of continuous improvement projects. Qualifications Must-Have Applicant must have a bachelor's degree, in technical, science or engineering preferred, with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience Must have shop floor experience working in an aseptic manufacturing facility. Requires strong oral, written, communication, presentation and interpersonal skills. Requires thorough knowledge of GMP’s and ability to handle multiple projects. Nice-to-Have Pharmaceutical manufacturing experience Experience working on Isolator/RABs Aseptic manufacturing. PHYSICAL/MENTAL REQUIREMENTS Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. Must be able to appropriately identify and escalate issues on a timely basis. Must be able to provide coaching and constructive feedback to operators. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Position is 6 am - 6 pm on a 2/2/3 schedule (Two on/Two off/three on) Must be able to work on weekend, off shifts and holiday as business demands. Work Location Assignment: On Premise The annual base salary for this position ranges from $68,600.00 to $114,300.00. 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 | (). 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. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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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. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . 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