Technical Specialist, MQS
$54,400–$68,000 year
On-siteTustin, California, United States
Job Summary
Write QMS records for deviations, out-of-tolerance calibration events, OOS results, OOL results, and OOT results. Investigate root causes of events using source documents and apply scientific principles to determine facts. Implement corrective and preventive actions (CAPAs) and propose viable solutions with final product impact assessments. Interface with witnesses, subject matter experts, and Quality Assurance to gather information and address GMP compliance questions. Manage records from assignment through closure while adhering to Good Manufacturing Practice and Good Documentation Practices. Perform statistical analysis of data and identify elements requiring efficiency improvements or revisions. Manage multiple records and projects simultaneously.
Required Qualifications
- B.S. degree in science or engineering (biological, chemical, or biomedical)
- 2+ years of technical writing experience, or an equivalent combination of relevant education and experience
- Excellent technical writing skills
- Expert experience in the use of MS Word
- Must be available to work holidays, weekends, or extended hours when needed
- You have a 'bring it on!' team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers
- Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position
Desired Qualifications
- Experience with writing QMS documents preferred
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