Permanent Direct- Hire
The responsibility of this position is to support the department in the daily upkeep of the Quality System, including document maintenance, internal audits, vendor qualifications, CAPAs and training. This individual may serve in the role of Clinical Quality support, providing quality oversight of activities in support of Clinical Trials. This individual may also be required to provide support in the development and administration of Client Quality Systems.
- Provide Quality oversight in support of Clinical Trials.
- Update Quality System documents as necessary to reflect current FDA and International Standards/Practices.
- Perform functions associated with Document Control.
- Schedule and perform Internal Audits.
- Schedule and perform Vendor Audits as assigned.
- Maintain the CAPA Log and coordinate with Staff/Departments to expedite completion of Corrective Actions.
- Maintain Training Files.
- Provide Quality Support to clients as requested.
- Perform other duties as assigned.
- B.A./B.S. or equivalent experience, preferable in a Science/Health related field.
- Two to Five years of work experience in Quality Assurance with a Medical Device/Pharmaceutical Company or CRO.
- CQA experience necessary.
- Qualified Internal/External Auditor; BIMO Auditing Experience a plus.
- Knowledgeable in regards to GCPs, GDPs, FDA Guidelines, ISO Standards.