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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.

Salary:
Base salary $80-120K.

RESPONSIBILITIES:
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.

QUALIFICATIONS:
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

Apply:
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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