Quality Compliance Specialist

About the role

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.

Responsibilities

• Enforce best aseptic practices/techniques within the Aseptic or Terminally Sterilized manufacturing areas per the Aseptic Observation Program.
• Provide real-time quality oversight during aseptic process simulations.
• Provide real-time quality oversight following planned and unplanned activities.
• Provide GMP walkthroughs ensuring regulatory compliance.
• Provide real-time quality oversight during environmental control deviations.

How You Will Achieve It

• Maintain 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).
• Enforce 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 GMPs 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.

Schedule

• Position is 6 am - 6 pm on a 2/2/3 schedule (Two on/Two off/Three on).
• Must be able to work on weekends, off shifts and holidays as business demands.

Pay

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.

Benefits

• 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.
• Health benefits to include medical, prescription drug, dental and vision coverage.