Sr QA Associate I

Job Description

Job Description: This function is responsible for supporting the daily manufacturing and facility operations along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise Deviations, and reporting operational metrics. This function supports and communicates events to shift leadership daily and thresholds when they are outside of the area of responsibility.

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. 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. 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. 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.

Minimum Education & Experience Requirements: Requires a Bachelor's degree in a scientific discipline or equivalent with a minimum of 5 - 8 years' experience in a Quality Assurance role in the pharmaceutical industry.

Knowledge/Skills Needed: Strong written and oral communication skills. A thorough understanding of the regulatory process from GLP through commercial manufacturing. Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues. Experience in sterile and aseptic product qualification and quality. Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines. Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations. Project management experience including scheduling, tracking and auditing. Experience in change management and deviation resolution including CAPA systems. Experience in participating in pharmaceutical technology transfer teams. Experience in the qualification of facilities, utilities, equipment and processes.

Personal Attributes Needed: Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks. Ability to increase others knowledge of US end European GMP regulations and guidance. Teacher level knowledge of GMP's. Demonstrated leadership skills with a high degree of independence and limited oversight. Demonstrated success with increasing levels of organizational responsibility.

About Us

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com

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, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.