The Quality Assurance Specialist will play an integral role within a cross-functional GXP QA Team and will support internal NBI Quality Systems and assist with cGMP manufacturing oversight. The position will assist in the maintenance of NBI controlled documents, conduct internal audits of systems and procedures and assist with review of cGMP manufacturing documentation. Review is conducted to ensure compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements.
Essential Duties and Responsibilities (including, but are not limited to):
- Review and approve the following CSP and internal documentation:
- process controlled documents
- maintain training files
- maintain documentation logs
- process change control requests to ensure compliance and completion within specified time frame
- Review master and executed batch records within a specified time frame
- Perform, track and report internal audit information for all areas of GxP compliance
- Prepare reports for management review of key statistics such as documentation review and internal audits
- Other essential duties as assigned
Knowledge of quality systems and regulatory compliance requirements within a commercial drug manufacturing operation is necessary as is experience with domestic and/or international drug development and approval process
- Must possess an awareness of the relationship between Sponsor companies and contract manufacturers
- A basic understanding of GLPs and GCPs is desired
- Critical thinker
- Strong communication skills
- Works well in a team environment, with the ability to drive results
Education and/or Experience:
- S. Degree in Chemistry, Biology, or related field.
- A minimum of 2-4 years of experience within the pharmaceutical or biotechnology industry.
- Relevant experience and knowledge of batch record review for the small molecule pharmaceutical industry is desired.
- Experience with electronic document management systems is desired.
- Previous experience with quality systems and in conducting internal audits.