Oxford Global Resources

Quality Assurance Consultant

Oxford Global Resources • $110K — $143K *
Lebanon, IN 46052In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Chemistry, Biology, or related field
  • 5+ years in Quality within Medical Device or Pharmaceutical sectors
  • Experience in small molecule and contract manufacturing
  • Knowledge of CAPA, Root Cause Investigation, and Validation types
  • Strong analytical, project management, and organizational skills
  • Excellent verbal and written communication abilities
  • Experience collaborating across all management levels

Responsibilities

  • Perform tactical reviews of documents, protocols, and reports
  • Document and batch disposition of API and drug products for clinical studies
  • Review and approve manufacturing records and change controls
  • Analyze and validate test methods and method validations
  • Evaluate manufacturing validation protocols and reports

Benefits

  • Opportunity to work on Phase 1-3 clinical studies
  • Engagement in a collaborative environment with management
  • Roles adaptable to differing levels of experience and training
  • Further development in the Quality and Manufacturing sectors
Full Job Description
Summary:

Perform tactical work and review a variety of documents, protocols, and reports.

Project Details:
  • Exhibit varying levels of experience and a solid progression of work and/or training
  • Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies
  • Review and approve manufacturing records, change controls, investigations and analytical data
  • Review and approve test methods and method validations
  • Review manufacturing validation protocol and reports


Job Experience:
  • Experience in small molecule manufacturing and contract manufacturing
  • Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline
  • A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc.
  • Excellent verbal and written communication skills
  • Demonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
  • Strong analytical skills
  • Effective project management and organizational skills are essential
  • Knowledge and understanding of quality
  • Manufacturing processes and procedures, planning, supply chain, inventory management

Hourly Rate: 53-69

Language Required: English

About Oxford Global Resources

Oxford Global Resources is a staffing and recruiting company that provides temporary and permanent staffing solutions to clients in a variety of industries. The company was founded in 1984 and is headquartered in Cambridge, Massachusetts. Oxford Global Resources offers a range of services, including contract staffing, direct hire, and temp-to-perm staffing. The company's clients include some of the world's leading companies in the biotechnology, pharmaceutical, and medical device industries, as well as government agencies and other organizations. Oxford Global Resources is committed to providing high-quality staffing solutions that meet the unique needs of each client.
Learn more about Oxford Global Resources
Size
500 employees
Industry
Staffing
Founded
1984
* Ladders Estimates

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