Quality Compliance Specialist - Rocky Mount, NC

Military Spouse Corporate Career Network•Rocky Mount, NC

2d•Onsite

About The Position

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. 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.

Requirements

Required skill set, education requirements, and experience for Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

Responsibilities

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.
Provide real-time quality oversight during aseptic process simulations.
Provide real-time quality oversight following planned and unplanned activities.
Provide GMP walk throughs ensuring regulatory compliance.
Provide 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.