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QC Data Review (Science & Biotech)
Durham, NC 27710
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Mar 19, 2020
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Job Description

This position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses and other technical documents for the release of raw materials, finished products and stability monitoring

• Technical review of raw data for the QC group
• Technical review of method transfer/verification protocols
• Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols
• Review, manage, and monitor stability trend tables
• Support investigations that arise in the QC testing of raw materials/finished products as needed
• Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scope of the investigation to determine the appropriate root cause
• Support the implementation of corrective actions, complete the trending analysis and determine product disposition as applicable
• This role will foster a collaborative relationship with manufacturing and laboratory personnel focused on high quality systematic investigations, meaningful corrective actions, and reducing the deviation generation rate. Provide support to determine appropriate corrective actions to prevent reoccurrence of the deviation
• Track effective measure of each implemented corrective action and take appropriate action if and when required
• Provides oversight and final review of investigations to ensure adherence to Familiarity with Empower 3 data collection system
• Working knowledge of cGMP’s and regulatory requirements as they apply to pharmaceutical testing.
• Familiarity with compendial methods (USP/NF, EP, JP, BP etc.)
• Experience in investigation/deviation management
• Technical writing skill with experience related to both laboratory and manufacturing investigations
• Excellent analytical abilities and use of investigation tools such as:
• Cause and effect analysis
• Failure mode analysis
• The why’s, the fishbone etc
• Proven written and verbal communication skills
• Experience with formal problem solving technique such as tools for root cause analysis
• cGMP, rigorous technical content, investigation clarity and completeness

B.S/MS degree in engineering/Chemistry/Scientific field Required
Minimum 3 years experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the pharmaceutical industry