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QUALITY SPECIALIST, STERILE MANUFACTURING

  • Job type: Permanent
  • Location: Charleston
  • Salary: $90000 - $110000 per annum
  • Job reference: BD072117
  • Sector: EPM Scientific, Quality
  • Date posted: 21/07/2017
Leading provider of services in pharmaceutical drug development seeking a Quality Specialist! 

  • Quality Specialist | Sterile Manufacturing
  • Charleston | South Carolina

My client specializes in analytical chemistry, formulation development, clinical packaging, oral drug delivery and contract manufacturing internationally. The company has experienced significant growth and we have continued to attract the most highly skilled professionals in the industry.

With nearly 1,000 employees operating out of multiple sites in the US and Europe.


KEY RESPONSIBILITIES:

The successful candidate for the Quality Specialist role will be required to:
  • Quality review and approval of documents, data, protocols, and reports.
  • Conduct internal quality audits and, inspections.
  • Deliver Quality evaluation and release of starting materials and intermediate bulk products.
  • Maintain quality databases and perform analysis and trending in support of site metrics.
  • Consultation on quality and compliance topics in areas of expertise
  • Assists with quality improvement initiatives as needed.
  • Assists with development of SOPs or other quality documents as needed.

QUALIFICATIONS AND REQUIREMENTS:

  • BA/BS degree in Chemistry, Biology or related field with 3+ years of relative quality experience or MS degree in a related scientific field with 2+ years quality experience related to the manufacturing of sterile dosage form products.
  • Experience with Controlled Substance reporting or handling
  • Experience with final product release, major equipment validation protocol review, process validation protocol review and APRs preferred.
  • Experience leading client audits as the facility host is a plus
  • Strong teamwork and organizational skills; excellent verbal and written communication skills;
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