Quality Assurance Specialist
About The Position
The Quality Assurance Specialist will perform a wide variety of duties to ensure compliance with applicable Regulatory Requirements in support of the Quality Management Systems (QMS). Provide documentation support to various Departments by performing functions that assure compliance with 21 CFR Part 111, 21 CFR Part 117 and 21 CFR Part 11. Functions include assistance in the development and implementation of quality systems and written procedures. This includes the generation, review and approval of QA documentation, and the ability to recognize process inefficiencies and provide recommended quality assured solutions.
Requirements
- High School Graduate
- Must speak, read and write English
- Minimum one year of MS suite; Word, Excel Skills and/or Training
Nice To Haves
- One year of ISO-9001 experience
- One year of working in an FDA regulated company
- Working understanding of 21 CFR 111
- Bilingual preferred, not mandatory
Responsibilities
- Assist with Document Control/MMR/Admin duties.
- Update/peer reviewer for SOP’s/WI’s/Forms/Etc.
- Assist protocol lead in execution of change control for equipment, process and facility qualifications that affect production.
- General support with recall/withdrawal investigations
- Support calibration activities – Calibration host for vendor visits, notifications to affected departments of upcoming calibrations, etc.
- NCR/CAPA activities - Investigate Non-conformances, assist with root cause analysis.
- Internal Audits of production activities – including planning, checklist, reports, Non-Conformance Reports’
- eQMS system – Proficient and train partnering departments in use of eQMS system.
- New Hire orientation QMS training
- Perform all other tasks as assigned by Threshold management.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
