QA Associate I-Operations-2nd Shift
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QA Associate I-2nd Shift
Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. Through our proven scientific, development and manufacturing capabilities, Alkermes is uniquely positioned to be an engine of innovative treatments for major clinical conditions specifically focused on central nervous system (CNS) disorders, such as schizophrenia, depression, addiction and multiple sclerosis.
Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts, as well as research and manufacturing facilities both in Athlone, Ireland and in Wilmington, Ohio. Currently an opportunity for a QA Associate I-2nd Shift is available at our Wilmington, Ohio facility. This rapidly expanding facility is within a 1-hour commute from the Cincinnati, Columbus, and Dayton metro areas.
For more information, please visit the Alkermes website at www.alkermes.com .
This function is responsible for supporting the daily on the floor activities related the manufacturing operations. Functions include area clearances, batch record review, discrepancy escalation, logbook review, AQL inspection, status tagging, maintenance work order review, and product shipping. This function thresholds events to Team Leaders and Senior Associates when they are outside of the area of responsibility.
The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Applies job related skills and understanding of policies and standards in completing tasks.
Minimum Education & Experience Requirements:
Requires a Bachelor’s degree in a scientific discipline or equivalent with a minimum of 1 - 2 years’ experience in a Quality Assurance role in the pharmaceutical industry.
Strong written and oral communication skills. 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 oral solid dose manufacturing quality and/or parenteral products desired. Experience in implementation and administration of quality systems for drug product manufacturing and quality control operations. Experience in the writing and review of procedures and other documents. Working knowledge of US Drug Product GMP requirements and associated guidelines is required.
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. Can work in a fast-paced environment with multiple issues open simultaneously.
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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