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Product Quality Specialist

Winchester, KY

Posted: 03/05/2021 Industry: Manufacturing Technician Job Number: JN -032021-12646

Job Description

Product Quality Specialist - New Product Development

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 - New Product Development
  • Location: Winchester, KY
  • Industry: Pharmaceutical
  • Hours: 1st Shift Mon-Fri
  • Salary: $29.00hr (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 Performance Expectations:
Requires a candidate with more advanced experience. They will work on new product development and all the activities supporting new products.

  • Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.
  • Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.
  • Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.
  • Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality system.

TECHNICAL:

  • Provide QA Technical recommendations based on trend analysis to eliminate future problems.
  • Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.

Reviews and approves technical documents, such as, but not limited to:
Technical Services Protocols and Reports;
Process Validation Protocols and Reports
Cleaning Validation Protocols and Reports
IQ/OQ/PQ Protocols and Reports;
MERs and material Specifications;
Product specifications;
Test methods;
Master Batch Records; and
Master Shipper Labels.
Change Control, as it pertains to the above validated/qualified systems and controlled documents

  • Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).
  • Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.

COMPLIANCE

  • Provide support to internal, client, and regulatory audits.
  • Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
  • Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.

Minimum Education and Experience:

  • Chemistry or chemical background Bach degree. 2-5 years of testing and data review.
  • Previous GMP working environment and documentation practices are strongly preferred.

EOE/ADA



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