General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals
Experience in managing complaint related to biologics, medical devices and solid dose products
Candidate must have proven computer literacy as well as independently understanding, following and implementing instructions.
Candidate must be well-organized, possess excellent oral and written communication skills, and have the ability to function in a fast paced environment. In addition, must be able to work independently or as a team player and collaborate with outside resources
Day to Day Responsibilities:
Interact and communicate with internal and external customers for reporting of complaints and adverse events (this may include intake and/or follow –up requests for information) Ensure that all complaints requiring customer responses are properly addressed as assigned
Understands the complaint handling process from initiation to closure
Process and close complaints in a timely manner
Maintain current knowledge of the Regulatory regulations
Serves as an internal review in order to assure regulatory compliance across all product lines
Other duties as assigned
Responsibilities: Initiate and coordinate product complaints. Interface with call centers, various Amgen sites and business partners to ensure call intake process compliance. Complete and approve product complaints requiring no further investigation.
Reconcile reported product complaints to ensure entry in product complaint database.
Perform return sample coordination and visual assessment.
Archive documents related to product complaints.
Requirements: Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience.
Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry.
Evaluate documentation and operation and documentation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data.
Basic project management skills.
Independently understand, follow and implement instructions.
Strong word processing, database and spreadsheet application skills.
Strong organizational skills with the ability to manage multiple projects or assignments.
"This posting is for Contingent Worker, not an FTE"