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Quality Assurance Specialist

Tailored Search
Durham, NC
  • Posted: over a month ago
  • $30 to $60 Hourly
  • Full-Time
Job Description

Responsible for review and/or approval of Deviations, Change Requests/SOPs, Training Material, Laboratory Investigations & Trend Reports; Supplier Program management; self-audits (in conjunction with LoB); QA presence & process confirmation on shop floor & improvement of quality processes:

  • Train users & actively support IT systems which are used in collaboration with Corporate Quality Systems related to Document Management, Records Management, Change Control & Training Documentation/Support processes
  • Support & implement improvement opportunities for the systems referenced above
  • Support review and approve cross functional investigations and root cause analysis
  • Support all Quality Management Systems (QMS) customer requests
  • Train & support customers in Quality Systems owned by QMS department
  • Coordinate & support business needs during audits & inspections
  • Execute the document creation & revision process for various NN documentation in order to support Process Responsible, including processing SOPs, System Specifications, etc. & ownership of the electronic systems associated with documentation control
  • Ensure local quality processes are in compliance with cross-functional requirements as well as regulatory requirements
  • Ensure compliant execution & monitoring
  • Drive corrective actions & quality improvement initiatives within production



  • Support incremental improvement of Quality Management Systems utilized at OFP Site Durham, such as Document Processing & Control, Records Management, Change Control, deviations, Audits & Inspections & Annual Product Review
  • Implement improvements or systems identified in QMS that support departmental or customer needs
  • Review & author QMS documentation, as required
  • Coordinate corporate document reviews & communicate document changes (corporate & local) to site
  • Control & organization of site records
  • Support the site retrieval/archival needs during audits & inspections
  • Support metrics for Quality System process improvements
  • Provide coaching to QA Compliance & Site regarding quality-related activities
  • Assist in plant-wide training on regulations, Quality systems & procedures
  • Ensure site compliance with Regulations, ISO standards & corporate/local SOPs
  • Review & approve change control requests
  • Participate in project teams as the compliance resource
  • Provide guidance to departments regarding quality-related activities
  • Support, review & approve cross-functional investigations & root-cause analysis
  • Participate in process confirmations & Go-Look-Sees
  • Participate in knowledge & experience sharing with other QA team members to assure compliance with company procedures, policies & objectives
  • Evaluate trend & report data for QMRs & APR reports
  • Perform other duties as assigned
  • Other accountabilities, as assigned


Required Qualifications

  • BA/BS degree, preferably in a life science, engineering or related field
  • Minimum of five (5) years of relevant work experience
  • Knowledgeable in the following systems:  Document Management, Change Control, Deviations, Audits & Inspections & Records Management processes/databases
  • Strong communication skills (verbal & written) & the ability to coach & train adult learners
  • Knowledge of pharmaceutical manufacturing processes
  • Strong attention to detail & excellent proofreading skills
  • Strong computer skills necessary to learn & train others regarding IT systems associated with QMS responsibilities
  • Willingness to learn new IT systems & develop progressive applications that improve processes & business


Desired Qualifications

Proven expertise in mentoring/development, change management, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams.

Company Description
Our team of industry-specific recruitment experts provides world-class service and unparalleled knowledge in their field. With a commitment to providing tailored search solutions for Pharmaceuticals Engineering, sales, finance, administrative and technology talent on a national platform, we are committed to earning your trust.

Tailored Search


Durham, NC



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