Manufacturing Quality Supervisor

Employer
Pfizer
Location
McPherson, Kansas
Posted
Jul 30, 2021
Ref
4819081
Required Education
Bachelors Degree
Position Type
Full time

ROLE SUMMARY

Manufacturing Quality Supervisor manages quality assurance personnel and activities associated with production processes through manufacturing and packaging. Directly manages reports that conduct Manufacturing Quality (AQL) sampling and auditing of primary and secondary packaging. Oversees, various tasks and training related to general sampling and ANSI sampling. Reviews and approves procedures and documents relating the auditing of manufacturing and the training of sampling colleagues. Leads a diverse team of individuals. Works interdepartmentally with visual inspection, pack, validations, and other site departments. Reviews batch record documentation. Monitors and reacts to the Cold Storage Monitoring System. Initiates investigations, corrective and preventative actions when required. Insures GMP compliance of the sampling program. Maintains QA databases for QA activities.

ROLE RESPONSIBILITIES

  • Supervises quality assurance personnel and activities associated with production processes through manufacturing and packaging.
  • Leads a tiered meeting system that allows shift by shift reporting, generating metrics and improvement initiatives.
  • Utilizes Quality concepts to identify needed improvements in process and product quality.
  • Evaluates deviation and complaint data for undesirable trends. Writes reports and makes recommendations based on these evaluations.
  • Assures GMP compliance for testing facilities, equipment and procedures.
  • Subject Matter Expert in quality sampling and auditing for Operations and Planning.
  • Participates in the investigation and action taken for deviations. Manages timely completion of investigations to support production operations. Maintains QA databases for QA activities. Writes and supports departmental investigations.
  • Monitors and operates computer systems for the monitoring of cold storage areas.

BASIC QUALIFICATIONS

  • 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
  • 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
  • Requires good written and verbal communication skills.
  • Requires tactful, persuasive, and assertive human relations skills.
  • Ability to manage, organize, problem solve and manage multiple priorities in a fast pace environment, while exercising leadership, diplomacy, and problem-solving skills, coordinating and working with all levels of Colleagues.

PREFERRED QUALIFICATIONS

  • Previous experience in GMP investigations, or QTS.
  • Previous experience in sterile manufacturing
  • Understanding of Basic Statistical methodologies

PHYSICAL/MENTAL REQUIREMENTS

  • PROBLEM SOLVING: Must provide direction to production when problems occur in the manufacturing environment. 

  • AUTHORITY TO ACT: Indirectly responsible for the quality of the product that is produced in this facility.  Decisions are made based on knowledge and experience, with input from the manager and/or QA Director as required.

  • AUTHORITY TO ACT: as the responsible person for in decision making regarding Manufacturing Quality sampling and auditing of product in all stages of manufacturing.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Position may require some weekend and off shift presence as business needs dictate.

Other Job Details:

  • Last Date to Apply for Job: August3rd 2021
  • Eligible for Relocation Assistance: No
  • Eligible for Employee Referral Bonus: YES

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.

Quality Assurance and Control

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