Quality Assurance Documentation Specialist - Oakwood Labs

This position is an excellent opportunity for a quality minded individual interested in working in a technology- based pharmaceutical company.

Essential job functions include:

• Generate, issue, reconcile, and archive batch records, protocols logbooks, and other controlled documents,
• Perform batch record review and work with various department to resolve and correct errors and ensure Good Documentation Practices are followed,
• Administer the electronic document, quality, and training management systems,
• Assist during all phases of the change management process,
• Processes and provides oversight of submitted change requests,
• Provides oversight of all routine reviews of documentation,
• Provides routine communications to the various departments and customers on outstanding tasks associated with the with the document control and change management process.

Attributes for the position:

• Prior experience in quality systems preferred
• Prior experience in pharmaceutical, GMP, or ISO manufacturing environment preferred
• Bachelor’s Degree in a science related field or equivalent experience

Oakwood Labs is a privately owned specialty pharmaceutical company focused on the design, development, and commercial manufacture of sterile injectable sustained- release microsphere products. This unique class of medications delivers therapeutic levels of drug to patients over days, weeks, months, or a year with a single intramuscular or subcutaneous injection. Products of this class have extremely high commercial potential.