Biogen Idec Research Triangle Park , NC 27709
The Manufacturing Support Associate II will be responsible for activities including; technical writing, project management and project execution.
Responsibilities include but are not limited to the following:
Complete daily activities and ensure all timelines are maintained and met
Initiate and monitor manufacturing documentation including Batch Production Records and Solution Lot Records
Coordinates and authors revisions of Manufacturing related documents, including BPR's, SLR's, Protocols, assessments and SOPs.
Investigates and troubleshoots discrepancies on the floor and implements corrective action
Support tech transfer process and communicate needs to cross functional groups
Performs applicable line functions in support of Manufacturing per cGMP guidelines.
Support manufacturing process and communicate needs to cross functional groups. This may include support for documentation prep, delivery, etc.
Identify improvement opportunities and effective strategies for site implementation.
Follow site procedures and comply with cGMPs
Highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities
Solid knowledge of business and manufacturing processes to support manufacturing operations
Solid understanding of the basic QA and cGMP principles
Moderate understanding of the roles of various functional groups within the company
Fundamental knowledge of change control
Intermediate to advanced skills in Microsoft Office
Fundamental level of technical writing skills
Ability to interpret and design manufacturing documents
Excellent oral and written communication skills
At least 2 years of relevant experience (additional experience required without Bachelor's Degree)
Bachelor's degree preferred. Other educational levels accepted based on related experience in the field.