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R1 Filling Manufacturing Quality Supervisor


Rocky Mount, NC
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Job Details

The Manufacturing Quality Supervisor will be responsible for supervising a specific shift to ensure that all manufacturing operations are operating within a state of cGMP compliance. This individual will supervise and coordinate the quality functions within Small Volume Parenteral (SVP) and Large Volume Solutions (LVS) manufacturing with guided over site and will be responsible for communicating effectively and for providing direction to employees on such shifts. The MQ Supervisor will be accountable for ensuring that all products manufactured meet the registration and cGMP requirements based upon all regulatory requirements, and for also ensuring that an assigned shift is working within the parameters of Pfizer's quality systems. The MQ Supervisor has the ability halt production operations if the process is not in compliance with quality standards. The supervisor will ensure that when quality-related issues arise, these issues are quickly elevated, so that sufficient resources are applied to correctly investigate, document, and lead corrective actions.

1. Provide daily supervision of MQ colleagues working on a specific shift.

2. Assure that the appropriate resources are utilized on a specific shift as they relate to CAPAs, root cause analysis, preventive actions, trending results and corrective actions, in accordance with facility standards and cGMP compliance.

3. Direct manufacturing staff to uphold quality and determine when manufacturing operations must halt to properly investigate production issues.

4. Work in conjunction with management to ensure that all aspects related to site cGMP compliance are followed by employees.

5. Work with the MQ Manager to ensure that all manufacturing and in process control procedures and specifications are followed as they relate to production, processes and equipment.

+ BA/BS required (science degree preferred).

+ Minimum of 1 year of related industry experience or demonstrated proficiency and understanding of the pharmaceutical industry.

+ 0-3 years of supervisory experience.

+ Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products.

+ Working knowledge of environmental monitoring and aseptic manufacturing.

+ Understanding of process validation requirements.

+ Minimum of 1 year experience in parenteral or related drug manufacturing with knowledge of small volume parenterals or large volume parenterals and/or MQE certification program.

**EEO Statement**

**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.

**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.

+ **Last Date to Apply for Job: December 19, 2017**

+ Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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