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Aseptic Compliance Supervisor

Company: Pfizer Inc.
Location: Rocky Mount
Posted on: November 17, 2019

Job Description:

ROLE SUMMARY
The primary function of the Aseptic Compliance Supervisor is to support and oversee the daily cleaning/disinfection activities for R1/R2 SVP Aseptic and Terminal Sterilized Filling/Support areas. The Aseptic Compliance Supervisor will be responsible for the sanitation colleagues across the shifts in aseptic and terminal sterilized areas. Candidate works directly with Manufacturing to ensure the seamless planning, execution, and tracking of the completion of sanitation activities to support Operations in SVP filling areas.
The candidate will also be responsible to performing necessary monitoring duties of the aseptic operation to ensure compliance in alignment with site SOPs and regulations. In addition, the candidate must be able to train new and existing colleagues on aseptic principles.

ROLE RESPONSIBILITIES

  • Perform necessary assessments of Aseptic and Terminal Sterilized SVP Filling operation and update necessary documents.
  • Able to present sanitation programs to auditors.
  • Accumulates key metrics for presentation to Management team, including gowning and aseptic technique observation.
  • Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.
  • Perform audits of sanitation, aseptic techniques, clean room behaviors, and gowning
  • Write investigations and implement CAPAs
  • Generate change controls for procedure updates
  • Perform daily room check inspections in the manufacturing areas
  • Provide support to aseptic process simulations (media fills)
  • Supervise team of direct reports and conduct performance evaluations
    BASIC QUALIFICATIONS
    • BS/BA Degree is required; Bachelor's in a technical or science field is preferred.
    • Requires strong/effective leadership ability. 2+ years of supervisory experience is preferred.
    • Requires thorough knowledge of GMPs.
    • Requires strong oral, written, communication, presentation and interpersonal skills.
    • Requires the ability to handle multiple projects.
      PREFERRED QUALIFICATIONS
      • Pharmaceutical manufacturing experience preferred.
      • Knowledge/experience in aseptic technique/cleanroom environment preferred.
        PHYSICAL/MENTAL REQUIREMENTS
        Must be able to function in stressful situations while being able to remain focused on the necessary requirements. Must be able to appropriately identify and escalate issues in a timely manner.

        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.

        Other Job Details:
        • Last Date to Apply for Job: 11/27/19
        • Eligible for Relocation Package
        • Eligible for Employee Referral Bonus
        • #LI-PFE
          Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

          Manufacturing

Keywords: Pfizer Inc., Rocky Mount , Aseptic Compliance Supervisor, Other , Rocky Mount, North Carolina

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