We are looking for a Quality Specialist II, working in the Pharmaceuticals & Medical Products industry in Irvine, California, United States.
Essential Job Functions:
Coordinates and processes all Master Specifications and Documentation-managed documents through the Change Control process/system with supervision as necessary.
Assists with word processing Master Specifications and Documentation SOPs as needed.
Assists in processing Product Launch Approvals (PLAs) and PLA Amendments as completed documents in CORAL.
The pay we are offering is 36 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Required Knowledge and Skills
Two-year degree: Science, Chemistry or Biology and/or related field preferred
Two to four years related experience
Working in a laboratory environment in a pharmaceutical, medical device or related industry including Quality Assurance preferred
Different computer software such as Microsoft Word, Excel, Access, Visio, Power Point, and Outlook preferred
Computerized systems such Documentum, Trackwise, and SAP preferred but not required
General cGMP, ISO, and FDA Requirements preferred but not required
General knowledge of pharmacopeias preferred but not required
Project management - multiple projects and priorities. Detail and quality-oriented while at the same time, being an efficient and effective time manager using risk management
Interpersonal written and verbal communication skills
Customer-oriented with sense of urgency of response to customers needs
Analytical thinking preferred
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.