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Quality Assurance Specialist

Morrisville, NC

Posted: 02/25/2021 Industry: Manufacturing Technician Job Number: JN -022021-12577

Job Description

Quality Assurance 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: Quality Assurance Specialist
  • Location: Morrisville, NC.
  • Industry: Pharmaceutical
  • Hours: Shift M-F 8:30 to 5pm - Remote / Training Onsite
  • Salary: TBD - Up to $36hr based on experience (Paid Weekly - Benefits Available)
  • Employment Type: 4 - 6 months
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 Summary:
The position is responsible for coordinating overall operations of the Quality Assurance function as related to specific assigned products and customers at the Morrisville site.
  • Primary quality liaison for clients and internal customers
  • Subject Matter Expert for the client products, processes and requirements.
  • Approval of Product Quality related customer complaint investigations
  • Approval of Events, Deviations, CAPAs (manufacturing)
  • Author Annual Product Review (APR) documents and trend reports
  • 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, review and approval of Master Batch Records, and author applicable sections of the Annual Product Review/Annual Quality Review.
  • Responsible for supporting internal, client, and regulatory audits through coordination and/or leadership of the audit backroom.
  • High level of attention to detail.
  • Proficient in problem solving, analytical skills and critical thinking.
  • Proficient in technical investigations, batch record review and technical writing
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Review documentation for accuracy and completeness.
  • Strong computer and appropriate communication skills (both written and oral) allowing direct interaction with external clients and RTP internal staff.
Qualifications:
  • Bachelor of science degree in related field (Chemistry/Engineering/Pharmaceutical Science)
  • Experience Requirements 2-3 years of experience in the pharmaceutical industry in Quality function.
  • Must have previous experience reviewing/ approving Product Quality Complaint Investigations.

EOE/ADA


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