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GCP QA Officer

United States   •  Permanent, Full time

Jim Gleeson is recruiting for a GCP QA Officer to join a clinical phase biotechnology company developing gene therapy treatments. The role will be based at their Pennsylvania office, but with significant home working possible.

Base salary $80-120K.

As GCP QA Officer you will play a critical role in supporting the Quality Management System. This role will be responsible of providing day-to-day assistance for QA activities, including the effective execution of overall company\'s QMS, with focus in supporting Clinical QA.

Key duties will include:
- Maintenance and monitoring of QMS performance, including the compilation of quality metrics in support of the QMS Annual report and management review
- Management of the QMS documentation structure and assuring all procedures, work instructions, and forms (including revision levels) are in compliance.
- Supporting and monitoring GxP training by recording and archiving of training records in a timely manner. Maintaining the training database.
- Supporting activities relating to deviations and CAPAs with focus on clinical deviation investigations.
- Working with others to further configure the electronic QMS system, deploy functional enhancements, and correct configuration issues.
- Conducting analyses of data pertaining to key performance indicators (KPIs), quality metrics.

As GCP QA Officer you will require:
- A relevant degree
- Extensive, industry based, Clinical Quality Assurance experience
- Experience of the use of a wide range of computerized systems
- Strong planning and time management skills
- Experience in the gene therapy field would be useful

Entitlement to work in the US is essential. Please quote reference 50261 in all correspondence.

You MUST be eligible to work in United States. Learn more

  • Agency: CK Group
  • Contact: Jim Gleeson
  • Phone: 01438 743 047
  • Reference: 50261
  • Posted: 26th March 2021
  • Expires: 23rd April 2021

CK Group

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