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Quality Specialist - Chemistry
Ref No.: 18-22639
Location: Durham, North Carolina
Title: Quality Specialist - Chemistry
Duration: 7+ months approx.
Location: Durham, NC 27712

Performs a variety of chemical analysis and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures. Assists inwriting and performing method validations and method transfers.
Assists in process validations. Conducts equipment validations IQs, OQs, PQs, and MQs, if necessary. Provides assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation.

Principal Accountabilities
  • Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
  • Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
  • Operate and maintain all analytical instrumentation and equipment as preestablished procedures.
  • Write, revise, develop and evaluate operational and maintenance procedures.
  • Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
  • Actively participate in investigations, problem solving and troubleshooting.
  • Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
  • Re-stock chemicals and consumables used in analysis.
  • Prepare and present data summaries (written and oral) as necessary.
  • Performs other related assignments and duties as required and assigned.

  • The incumbent must have a BS degree in Chemistry in addition to 0- 2 years minimum relevant experience.
  • Graduate degree (MS Preferred) with 0-1 year minimum experience. Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relate