- Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
- Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
- Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies and procedures.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient in Excel, PowerPoint, Visio, Word, etc. In addition to experience working within shared work environments.
- Strong interpersonal, written, presentation, communication and investigation skills with the ability to engage with a diverse range of individuals across all levels of the organization.
- Education and Experience:
- Specialist; minimum of BA/BS in Engineering/Science discipline with 2+ years experience working in a cGMP environment.
