Associate III, Quality Control Chemistry

Job Description

The Quality Control Associate III will support the management team to ensure that laboratory and Quality systems within the QC Chemistry department remain in compliance with Biogen Idec and industry cGMP standards.

Additionally, the Associate III will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing. The Quality Control Associate III has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, leading investigations, discussions pertaining to strategic initiatives, personnel development, and testing-related issues.

Importantly, the Associate III is responsible for generating, communicating, and coordinating test results with key Chemistry customers, as appropriate, to support departmental, site, and global initiatives.

Finally, the Associate III will have cross-departmental interaction with peers to ensure timely communication of issues to support QC and manufacturing initiatives.

The Quality Control Associate III will support the management team to ensure that laboratory and Quality systems within the QC Chemistry department remain in compliance with Biogen Idec and industry cGMP standards.

Additionally, the Associate III will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing. The Quality Control Associate III has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, leading investigations, discussions pertaining to strategic initiatives, personnel development, and testing-related issues.

Importantly, the Associate III is responsible for generating, communicating, and coordinating test results with key Chemistry customers, as appropriate, to support departmental, site, and global initiatives.

Finally, the Associate III will have cross-departmental interaction with peers to ensure timely communication of issues to support QC and manufacturing initiatives.

• Performs release and stability testing, as needed. Performs sound technical review for data and documentation generated for or by QC Chemistry
• Authors or reviews investigational protocols, investigational reports, change control requests, validation protocols, and validation reports, etc.
• Supports the execution of the transfer, qualification, method development, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group
• Provides technical leadership through effective project management including laboratory investigations
• Support maintenance of laboratory systems to ensure data integrity
• Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Chemistry laboratory
• Actively provides leadership and mentoring as needed to aide in the development of their peers

You are task driven, focused and/or willing to learn. You are a collaborative person capable of being both agile and customer focused.

• Bachelor's degree or Associate's degree (+2 years lab experience) in biological/chemistry/life sciences
• HPLC experience
• Possess technical knowledge regarding Quality Control Chemistry release and stability methodology
• Demonstrated instrument/method troubleshooting skills
• Knowledge of FDA/EMEA regulations and compliance

• Prior GMP experience in industry, especially in QC Chemistry
• LC MS, HPLC, Dissolution, Karl…