Quality Compliance Specialist - Night Shift

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

In this role, you will:

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.

Other duties may include:

• • Oversee daily cleaning and disinfection activities in assigned areas, ensuring support for sanitation colleagues across shifts in aseptic and terminal sterilized areas.

  • Perform assessments of aseptic and terminal sterilized filling operations and update necessary documents.

  • Present sanitation programs to auditors and compile key metrics for management, including observations on gowning and aseptic techniques.

  • Maintain knowledge of cGMPs and stay informed on emerging regulatory and compliance issues related to aseptic manufacturing.

  • Conduct audits of sanitation practices, aseptic techniques, clean room behaviors, and gowning procedures.

  • Generate change controls for procedure updates and perform daily room check inspections in manufacturing areas.

  • Provide support for aseptic process simulations, such as media fills.

  • Contribute to project tasks and milestones, organizing work to meet deadlines.

  • Learn and apply basic team effectiveness skills within the immediate work team, making decisions within limited options to resolve basic problems under the supervisor's direction.

  • Work in a structured environment using established procedures, seeking guidance from colleagues, with regular reviews of work for technical judgment, completeness, and accuracy, and exercising judgment with reliance on the supervisor.

  • 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 hyper care 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.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree 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 Strong oral, written, communication, presentation, and interpersonal skills

• Must have shop floor experience working in an aseptic manufacturing facility.

• Thorough understanding of GMP

• Ability to manage multiple projects simultaneously

• Knowledge and experience in aseptic techniques

• Proficiency in conducting audits of sanitation, aseptic techniques, clean room behaviors, and gowning

Bonus Points If You Have (Preferred Requirements):

• Exceptional leadership and adept people management abilities

• Knowledge of change control process (i.e. document writing and editing

• Experience in presenting sanitation programs to auditors

• Experi