Process Control Specialist - Oakwood Labs - Cleveland, Oh
Oakwood Laboratories is a privately owned specialty pharmaceutical company focused on the design, development and commercial manufacture of sterile injectable sustained release pharmaceuticals.
This unique class of products delivers therapeutic levels of drug to patients over days, weeks, months or even years with a single intramuscular or subcutaneous injection. Products of this class have extremely high commercial potential.
Process Control Specialist
Essential Job Functions Include:
Generating standard operating procedures, specifications, test methods, and protocols to support company projects Submitting change requests to existing documents based on company initiatives Generating batch records Reviewing and grading quizzes
Desired skills and experience include:
Prior technical writing experience Prior experience with electronic quality management system
Experience working in an ISO certified or FDA regulated manufacturing environment preferred
Experience working in a Quality department Working knowledge of a cGMP environment preferred
Attention to detail, accuracy, and strong written and verbal communication skills
B.S. in a science related discipline or equivalent work experience
Ability to use Microsoft Word, Excel, and PowerPoint
Associated topics: biochemistry, bioinformatic, biomechanics, biomedical, biomedical engineer, bioprocessing, genetic, medical, metabolic, msat
Oakwood Labs, headquartered in Cleveland, OH, is an emerging, technology-based specialty pharmaceutical company focused on hard-to-develop generic and quasi-generic, sustained-release and small molecule injectables, as well as contract manufacturing.
Since 1997, Oakwood has been committed to developing pharmaceutical products that provide enhanced therapeutic effects for patients. Oakwood is an industry leader in sustained-release injectable pharmaceutical development, developing and owning a patented microsphere-based drug delivery platform – called Chroniject™
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