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Manufacturing Support Associate II

Expired Job

Biogen Idec Research Triangle Park , NC 27709

Posted 4 months ago

Job Description:

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

Qualifications

  • 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)

Education

Bachelor's degree preferred. Other educational levels accepted based on related experience in the field.


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Manufacturing Support Associate II

Expired Job

Biogen Idec