The Quality Compliance Specialist provides quality oversight in manufacturing ensuring compliance with aseptic practices GMPs and regulatory standards during aseptic processes and environmental control deviations.

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 Conventional Aseptic manufacturing.

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

• 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.

Other Job Details:

• Last day to apply: June 2nd
• Work Location Assignment: On Premise

The annual base salary for this position ranges from $68600.00 to $114300.00. 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.
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.
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.
Pfizer endeavors to make www.pfizer.com/careers 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 [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Manufacturing