Quality Compliance Specialist

Pfizer • Rocky Mount, NC

1d • Onsite

About The Position

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.

Requirements

• 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 Haves

• Pharmaceutical manufacturing experience
• Experience working on Conventional Aseptic manufacturing.

Responsibilities

• 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.
• 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)
• Meet Aseptic Observation Program Monthly/Annual required metrics
• Drive continuous improvement through implementation of continuous improvement projects.

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
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED