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Manufacturing Quality Supervisor

Pfizer


Location:
Rocky Mount, NC
Date:
02/08/2018
2018-02-082018-03-11
Pfizer
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Job Details

**ROLE SUMMARY**



**The MQ Supervisor** will be responsible for supervising across different shifts to ensure that all manufacturing and packaging operations are operating within a state of cGMP compliance. This individual will supervise and coordinate the quality functions within Small Volume Parenteral (SVP) or 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 to shut down a production line if product is not meeting 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.







**ROLE RESPONSIBILITIES**







+ Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with GMP compliance and regulatory guidelines.



+ Implement process improvements with a focus on quality processes.



+ Provide input and decision making for quality on the shop floor with regard to manufacturing and deviations. Provide corrective action as necessary.



+ Work closely with Manufacturing and other support functions to troubleshoot during unexpected events.



+ Provide daily supervision of MQ employees & QA Specialists (where applicable) working on a specific shift.



+ 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.



+ Direct manufacturing staff to uphold quality and determine when manufacturing lines need to be shut down to investigate production issues.



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



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







**QUALIFICATIONS**







+ BA/BS required (science degree preferred).



+ Minimum of 2+ years of leadership, coaching, supervisory experience within a manufacturing environment required with demonstrated proficiency and understanding of the pharmaceutical industry.



+ 1 - 3 years of experience with GMPs and in compliance driven environment with FDA and regulatory body experience



+ Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.



+ Strong oral/written communications skills and leadership skills required.



+ Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.



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



+ Working knowledge of environmental monitoring, aseptic manufacturing in a clean room environment desirable.



+ Understanding of process validation requirements.



+ Available to work off-shifts and/or weekends.







**PHYSICAL/MENTAL REQUIREMENTS**







+ Stand up to 8 to 10 hours



+ Sit up to 2 to 4 hours



+ Occasionally lift a maximum of 20 pounds 3 times per shift



+ Walking and climbing stairs



+ Work around and close to moving equipment







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**







+ Ability to work overtime as required supporting business needs.



+ Ability to gown aseptically for entry into the Aseptic core areas.



+ Ability to follow area specific gowning requirements for entry in to the Terminally Sterilized areas and/or other classified solutions/filling areas.







**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.







**Other Job Details:**







+ **Last Date to Apply for Job: 2/21/2018** 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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