Description:
Executions completing, pending reports, open investigations Technical Writing and documentation Investigations for FDA/ISO/Root Cause/CAPA/ Compliant with ISO Regulations and Protocol Knowledge of FDA regulations, pharmaceutical GMPs (21 CFR 210, 211 and 820), and/or ICH regulations. Verbal communication and technical writing skills with strong attention to detail Assist with technical writing and any other activities assigned. Completing, pending reports, good writing and documentation skills (CAPA, NCR)
Skills:
Investigation, aseptic technique, technical writing, validation, validation testing, pharmaceutical, ISO, FDA, Quality assurance, Capa, Audit, Gmp, Root cause analysis
Top Skills Details:
Investigation,aseptic technique,technical writing,validation,validation testing,pharmaceutical,ISO,FDA
Additional Skills & Qualifications:
Bachelor's Degree in Science Related Field 3+ Years of QA or QC experience in a Med Device or Pharmaceutical (cGMP and FDA regulated) Understand Aseptic Techniques/Practices/FDA and ISO Regulations 2 Years Experience Executions completing, pending reports, good writing and documentation skills (CAPA, NCR) Knowledge of FDA regulations, pharmaceutical GMPs (21 CFR 210, 211 and 820), and/or ICH regulations. Excellent user knowledge of Microsoft Excel, and Word.
Experience Level:
Intermediate Level
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.