Career Opportunities
Department: Quality Assurance
Job Title: Senior Quality Assurance Specialist
Description:
RESPONSIBILITIES
The Senior Quality Assurance Specialist will participate in all activities of the NeurogesX (NGX) Quality Assurance (QA) team to ensure cGMP compliance. The candidate will closely work with internal departments to communicate requirements and ensure efficient document flow. In particular, this position will:
- coordinate change control documentation for review, ensure change control justification is generated, and certified copies are obtained.
- perform consistency review of change requests with the internal systems and procedures.
- perform initial review of contract manufacturer documents such as executed batch records, certificate of analysis, specifications etc.
- maintain the document control data base.
- maintain change history of analytical methods.
- update Regulatory Affairs of document changes, and generate documents for archival.
Job Requirements:
- B.S. in a scientific discipline.
- Experience in the area of Quality Assurance and document change control as it relates to regulator guidelines and the company’s compliance standards.
- Minimum of 4 years experience in the pharmaceutical or biotech industry
- Minimum 1 - 2 years in Quality Assurance with a focus on document change control.
- Ability to work independently and use judgment in reviewing documentation.
- Excellent attention to detail
- Strong written and oral communication skills
- Strong computer skills including experience with Microsoft Access are a plus.