QA Specialist - Complaints/Investigations
Our client has an urgent, immediate temporary need for an experienced Quality Assurance Specialist.
The majority of job duties will entail handling and investigating commercial product complaints and investigations. There is no preference for QA GMP acquired in either Pharma or Med Device.
This position is a contract set for a minimum of three months. Compensation is competitive.
- Log-in incoming product complainants, evaluate them and determine their category and how the investigation will be conducted. Independently, write the rationale for assessing each complaint including impact to other batches.
- Write remediation reports related to product complainants. Issue appropriate corrective and preventive actions (CAPAs). Follow up until complaints are closed
- Implement effective Quality product complaints processes including investigation procedures, documentation systems, tools, metrics and measurable improvements. Recommend if changes are needed too current procedures and author other procedures.
- Ship samples from different sites for testing, ensure appropriate shipping conditions
- Conduct audits and manage outside vendors.
- Independently complete deviations occurred at Contract Service Providers
- BA or BS degree in a scientific discipline, or comparable experience. An advanced degree in sciences would be a plus.
- In-depth knowledge of pharmaceutical cGMPs (US and EU)
- Must have excellent verbal, written, interpersonal, organizational and communication skills
- Experience in Pharmaceutical or Biotech Manufacturing Operations
- Cross-functional experience in three or more areas (i.e. Quality Assurance, Product Quality Complaints, Manufacturing, Regulatory, Medical Information, Pharmacovigilance etc.) is required