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.
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 12
Work Location Assignment: On Premise
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
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offPerformance bonusParental leave
Additional Information
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.
Pfizer · - North Carolina - Rocky Mount