Description:

　　Executions completing, pending reports, good writing and documentation skills Investigations for FDA/ISO/Route Cause/CAPA/6M/ in a Medical Device Field Familiar with media fill, water qualification, writing protocol PPQ / Requalification’s Risk analysis, process validation, qualification required for new products, processes, and equipment in addition to any changes to existing products, processes and equipment. Manage and successfully execute several validation projects concurrently by teaming up with internal and external contacts with minimal supervision. Capable of meeting project objective timelines by successfully planning, tracking and executing validation projects that may potentially cover all three shifts of manufacturing. 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 Create and/or update intra and interdepartmental procedures, policies, and supporting documentation. Demonstrate problem-solving and troubleshooting skills. Stay current with validation regulatory requirements. Assist with technical writing and any other activities assigned.

　　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.