Quality Compliance Specialist
Pfizer
This listing was originally posted on Pfizer's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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.
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 GMP’s and ability to handle multiple projects.
Nice-to-Have
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 2nd
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
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
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