Responsible for quality system functions including: quality investigations, deviation reporting, and tracking of investigations, deviations and associated corrective and preventative actions (CAPA). Processes, and reviews workflows submitted to create or revise documents in the DocCompliance Document Management system. Responsible for data review of Annual Product Review reports prior to approvals.
- Assigns Quality Investigation (QI) numbers and tracks all quality/GMP investigations and deviations
- Assists with Quality Investigations and Deviation history review
- Administers corrective and preventative action (CAPA) system
- Keeps QA Management and other appropriate departments informed of the status of Quality Investigations and Event Notices
- Performs a trend analysis of all deviations initiated within each review period. Submits a report, with recommendations, to Sr. Management.
- Ensures that new or revised Standard Operating Procedures and Forms comply with FLI requirements and current Good Manufacturing Practices (cGMPs) are are not in conflict with other written procedures
- Processes and reviews workflows in the DocCompliance system for Standard Operating Procedures and forms
- Completion of data review for all Annual Product Review reports
- Participates in audits and inspections by FDA or 3rd party customers.
- Assists in Internal Audits
- Writes and revises QA SOPs and forms
- Back-up for Info-Train SOP revisions and Employee status changes
- Back-up for Change Control processes
- All other duties as assigned.
Knowledge, Skills & Abilities:
An established knowledge of Food and Drug Administration (FDA), cGMP and regulatory reporting requirements. High degree of proficiency with verbal and written communication skills and effective customer service skills. Must possess a proficient working knowledge of Microsoft Office suite, including knowledge of word processing, spreadsheet and database applications; PowerPoint experience is preferred. Must be self-motivated; organized; detail oriented/accurate; able to work independently to resolve problems.
Education & Experience:
Requires a Bachelors degree in a scientific discipline, or an equivalent amount of education and 5 to 7 years experience, with a minimum of three years experience in the pharmaceutical or medical device industry, with at least three years in quality (preferred Pharma QA).
EO Employer M/F/Vets/Disabled