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The Quality Control Chemistry Team Leader/QC SPECIALIST V will be the technical leader responsible for the technical work for a small group of chemists performing testing to meet QC cycle times and to comply with all Alkermes criteria and cGMP regulations. He/she will apply knowledge, experience and initiative in resolving highly complex non-standard problems and developing recommendations.

Responsibilities:

• Recognize and takes ownership when problems occur, makes necessary decisions and escalates as necessary.
• Communicates decisions to wider group and follows up to ensure compliance with decision.
• Accountable for all people management, technical and scheduling issues in the absence of the supervisor.
• Leading and participating in improvement projects.
• Lead Root Cause Analysis process and write up within department complex issues, identify the solution and implement.
• Monitor the effectiveness of preventative measures and has the ability to re-assess and continuously improve.
• Adapts to changes to ensure all work schedule activities are completed as required.
• Independently coordinates activities with others both inside/outside their area.
• Prepares/ facilitates peer to peer shift handover and resources for areas of their responsibility in the absence of supervisor.
• Acts as a positive role model to all team members' e.g punctual, prepared and high standards.
• Takes responsibility for Lab Services within all discussions; owning the opinion managing risk and assessing impact.
• Acts as a coach and mentor to other team members.
• Understands how own contribution impacts site goals.
• Train other group members.
• Troubleshooting methods and equipment.
• Performing analyses.
• Reviewing and reporting test results.
• Developing new methods as necessary.
• Writing and reviewing deviations/ lab investigations.
• Writing and reviewing test methods, reports and validation protocols.
• Conducting method transfers and validations.

Qualifications:

• Bachelors Degree in Chemistry with approx. 8 years of laboratory experience or 
• Masters Degree in Chemistry with approx. 5 years of laboratory experience
• Ability to manage technical issues and root cause analysis
• Ability to represent self in a regulatory inspection
• Specific understanding of the instrumentation and practices of LC, GC, GPC, particle size analysis, DSC, Karl Fischer titrator, FTIR spectrophotometer etc.
• Specific understanding of chromatographic data acquisition and analysis software (empower), LIMS, SAP, track-wise etc.
• Specific understanding of the application of statistical concepts to the calibration of assays and interpretation of results.
• Knowledge of analytical instrumentation such as GPC, particle size analyzer, and/or.
• Ability to manage technical issues and troubleshoot across a shift and cross functionally where required.
• Adapting to changing priorities (positively/ constructively)Ability to anticipates problems ahead of time and develops solutions.
• Ability to influence, listening & values/recognition of all opinions and represents Lab services in a diplomatic way facilitating open discussion across all functions.
• Ability to work hard and contribute to an enjoyable rapidly changing working environment.
• Proactively achieves results for the best of the organization.

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Mass