Senior Quality Assurance Associate
3 days ago
The Quality Assurance Senior Associate - Laboratory Support is responsible for supporting daily operations and monitoring compliance of the laboratory.
Key Responsibilities- Act as QA Lab Support representative on special committees and teams.
- Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements.
- Actively participate and contribute to the QA mission and objectives.
- Deliver key business messages to superiors and/or peers in a timely manner.
- Develop metrics and other tools to measure QA Lab Support and/or systems.
- Understand departmental KPIs and their impact on site targets.
- Interact with laboratory personnel to ensure cGMP compliance and provide general guidance and support.
- Review and approve SOPs, analytical protocols, test methods, training plans, work orders, and controlled forms.
- Provide input for, review, and approve technical protocols and reports, stability protocols and reports, and instrument qualification documents authored by the laboratories.
- Review, approve, and oversee the change control process for minor change controls generated by the laboratory, including amendments and extensions.
- Act as the QA Contact and QA Approver for laboratory investigations, incidents, minor deviations, environmental excursions, and executed CAPA.
- Capable of identifying solutions and following through to implementation.
- Has the capacity to monitor the effectiveness of system and process changes and continuously improve.
- Excellent communication and documentation skills.
- Demonstrates empathy and active listening and provides opportunities for individuals to talk freely in an open honest discussion setting.
- Communicates well in team settings.
- Seeks to understand others with diverse viewpoints and expertise.
- Builds strong relationships with stakeholders external to QA and takes advantage of these relationships to identify new opportunities.
- Bachelor's in Chemistry or Biology (or related field) with 5+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or, Master's in Chemistry or Biology (or related field) with 4+ years of Pharmaceutical Quality experience and/or cGMP Laboratory experience.
Alkermes is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
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