Posted in Engineering about 4 hours ago.
Type: Full Time
Location: Wilmington, Ohio
The Quality Assurance Senior Associate - Laboratory Support is responsible for supporting daily operations and monitoring compliance of the laboratories.
MAJOR RESPONSIBILITIES
Major Responsibilities |
Estimate percentage of time spent on each responsibility (Must add to 100%) |
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. | 30% |
Interact with laboratory personnel to ensure cGMP compliance and provide general guidance and support. In these interactions, act as an ambassador of quality and compliance, driving quality culture by actively mentoring or coaching within the QA and laboratory organizations. | 20% |
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. | 20% |
Review, approve, and oversee the change control process for minor change controls generated by the laboratory, including amendments and extensions. | 15% |
Act as the QA Contact and QA Approver for laboratory investigations, incidents, minor deviations, environmental excursions, and executed CAPA. Assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place. Able to lead exercises in root causes analysis within areas of support or cross-functionally for complex issues. Act as an internal auditor, leading audit when necessary. | 15% |
QUALIFICATIONS
Years of Experience
Working Environment/Physical Demands
Alkermes, Inc. 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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PDN-9d08157e-e07e-415f-9f18-c15f075e3fd7
Alkermes, Inc.
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Alkermes, Inc.
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