Quality Manager III
Discovery Drive, SWDD Swiftwater, PA 18370
- Represent the site quality organization with expertise in Data Integrity.
- Maintain currency with U.S. and European regulations related to Data Integrity.
- Perform Data Integrity risk assessment of manufacturing and laboratory systems.
- Evaluate proposed and existing manufacturing equipment, instrument systems and laboratory applications for Data Integrity gaps.
- Relevant quality assurance experience (comparable to 10+ years) including expertise in GMP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry
- 5+ years working in a GMP regulated environment
- 3+ years of experience quality role
- 3+ years of experience in a computer systems validation
- Or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job.
Required Knowledge, Skills and Abilities • Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity
- Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Bachelor’ s degree (or equivalent) required in a relevant scientific discipline
EEO REQUIRED STATEMENT:
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.