Product Quality Specialist

Winchester, KY

Posted: 03/05/2021 Industry: Manufacturing Technician Job Number: JN -032021-12651

Job Description

Product Quality Specialist

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: Product Quality Specialist
  • Location: Winchester, KY
  • Industry: Pharmaceutical
  • Hours: 1st Shift Mon-Fri
  • Salary: $25.00hr (Paid Weekly - Benefits Available)
  • Employment Type: Long Term Contract to Hire

Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Job Scope:
The Product Quality Specialist provides world class customer service, with the highest levels of integrity, focused on quality and compliance in partnership with C-WIN customers and internal organizations. This position serves as a representative for their client(s) within the internal web site.

Job Performance Expectations:
Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.

  • Serves as NPI support member for products/processes which may not have a specified QA representative.
  • Responsible for supporting internal, client, and regulatory audits through coordination and/or leadership of the audit backroom.
  • Responsible for maintaining systems and procedures to monitor the health of the quality system, and show an awareness of their clients manufacturing floor areas audit readiness.
  • Responsible for performing statistical analyses and providing metrics for the Quality team to Management on a routine basis.
  • Responsible for the maintenance, development and nurturing of the client partnership to ensure alignment and consensus.
  • Effectively coordinates functions of internal QA organization with customers and necessary departments. Specifically: reviewing and closure of investigations (major and minor deviations), reviewing and closure of non-critical customer complaints, reviewing executed batch records and support data, performing trending of product specific data, final disposition of batches, review and approval of Master Batch Records, review of site utility readings, review and approval of manufacturing calibration records, review and approve qualification reports, review of Quality Agreements, and author applicable sections of the Annual Product Review/Annual Quality Review.
  • Effectively maintains client data sets including metrics, trackers, business review material, and client updates to QLT/ELT/SLT.
  • Interfaces with the Operations Groups and Customer Service departments as needed to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure highest quality standards and regulatory compliance.
  • Coordinates key systems including Customer Complaints, Batch Records and other functions impacting the Quality area related to assigned products and clients.
  • Supports Quality Compliance department during FDA and other agency inspections as well as customer and internal audits.
  • Interfaces with all other departments to ensure coordination and compliance with SOPs and cGMPs via observation of existing processes and implementation of continuous improvement initiatives.
  • Provides all additional Quality Assurance support and functions as specified by their Supervisor.
  • Maintain effectiveness of the Quality System components relevant to this position.
  • Other duties as assigned.

Minimum Education and Experience:

  • Previous GMP working environment and documentation practices are strongly preferred.


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