Associate II, Quality Control

• The QC Associate I/II is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at Biogen.
• Performs testing, and all associated activities associated with this testing.
• Responsibilities include, but are not limited to, training, testing support, support for qualification/validation/certification activities as appropriate, robust and compliant cGMP documentation practices.
• A fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions.
• Adherence to all GMP requirements, familiar with FDA/EMA resources, effective interactions/communication with Quality management, personal development, and support of investigations.
• Able to work effectively within the group.
• Perform testing, initiate deviations, IA, and A/A. Capable to perform up to 60% of the assays in the group.
• May author or design protocols, change control requests, and Quality Technical Reports, as directed etc. perform document revision. Provides technical leadership as a subject matter expert in one or more disciplines.
• Provides timely review/corrections for data and documentation. Perform sample approval according to agreement.
• Participates in the execution of method development, method qualification, facility certification, analytical improvement projects, and validation of analytical methods in collaboration with teams as appropriate.
• Supports maintenance of effective laboratory systems, incl. instruments and equipment to ensure integrity of all laboratory results.
• The QC Associate I/II will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology and/or EM and UM skills.

The position requires but is not limited to the following:

• Understanding of basic scientific principle
• Ability to communicate with peers and management
• Effective organizational skills
• Ability to multi-task and coordinate multiple activities in parallel
• Developing or demonstrated problem solving skills
• Developing or demonstrated instrument/method troubleshooting skills
• Good working knowledge of operations/quality systems
• Completes deliverables within targeted timeframes with good quality
• Able to draw conclusions from data interpretation
• May have technical writing skills, author’s reports with input & guidance and conducts compliance/work impact assessments as appropriate. Works on process improvements, actively supports management & QC teams.

Associate I:

• 0-2 years of relevant experience (B.S. degree)
• 8+ years of relevant experience (A.S. degree)

Associate II:

• 0-2 years of relevant experience (M.S. degree)
• 2-3 years of relevant experience (B.S. degree)
• 4 years of relevant experience (A.S. degree)

All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-618-8925 ASAP! I want to know more about your preferences.
If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!