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Senior Quality Assurance Scientist

Location : High Point, NC
Job Type : Direct
Reference Code : CRC_SQAS
Hours : Full Time
Required Years of Experience : 8+
Required Education : Not specified
Travel : No
Relocation : No
Industry : Pharmaceutical

Job Description :

THE COMPANY:



  • Stable, high-growth specialized pharmaceutical manufacturer with a global presence and North American HQ

  • Comprehensive product/services offering to include end-to-end solutions for clients as a true one-stop-shop provider in their industry

  • Strong benefits offering to include medical/vision/dental, 401k, excellent PTO, and much more


THE SCOPE OF THE ROLE:



  • Perform a wide variety of QA activities to ensure compliance with internal procedures, applicable US regulatory requirements, and customer requirements for drug substances under clinical development

  • Review and approve documents such as SOPs, manufacturing batch records, packaging and labeling records, test methods, specifications, stability protocols and reports

  • Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release

  • Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products

  • Perform product complaints investigations

  • Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.

  • Assist with hosting and responding to client audits

  • Assist with developing and maintaining company’s quality system

  • Support continuous improvement of quality systems; author new, revise existing and may review department procedures and/or forms

  • Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)

  • Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third-party audits

  • Serve as a backup to Senior Document Control Specialist, Associate Quality Assurance Scientist and Sr. Quality Assurance Scientist

  • In the absence of the Director, Quality Assurance provide guidance to the QA department.

  • Other duties as assigned and / or developed by Director, Quality Assurance


Required Qualifications :

THE BACKGROUND PROFILE:



  • Bachelors of Science Desired: Bachelors of Science in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy, Engineering, or related field.

  • 8+ years of experience in QA, with a minimum of 3 years supporting GMP manufacturing, within the pharmaceutical industry

  • 5+ years handling quality system investigations, CAPA, change control, etc.

  • Works independently with minimum supervision to accomplish goals

  • Good working knowledge and understanding of 21 CFR Parts 210, 211, and ICH Q7


 

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