QUALITY ASSURANCE SPECIALIST
Seeking a Specialist QA WITH EXPERIENCE IN VALIDATIONS AND ASEPTIC PROCESS
to perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
Skills and Qualifications
- Approve process validation protocols and reports for manufacturing processes.
- Request quality on incident triage team.
- Support Automation activities
- Release of sanitary utility systems.
- Represent QA on NPI team.
- Review and approve MPs.
- Approve environmental characterization reports, planned incidents and change controls.
- Provide lot disposition and authorize lots for shipment.
- Approve NC investigations and CAPA records.
- Review and approve EMS/BMS alarms.
- EXPERIENCE VALIDATIONS AND ASEPTIC PROCESS
- Initiate and lead cross functional teams
- Presentation skills
- Good interpersonal skills and problem solving
- Project Management skills
- Strong organizational skills
- Fully bilingual: oral and written
- Leadership and team-building
Doctorate degree in sciences or Master's degree in sciences and 3 years of directly related experience
or Bachelor's degree in sciences and 5 years of directly related experience.
Integrated Technology and Compliance Services is an Equal Opportunity Employer