QC Analyst II

Job Description

The QC Analyst II is responsible for sampling and inspecting for quality incoming raw materials such as active pharmaceutical ingredients, excipients, components, and processing aids. This role is also responsible for creating or revising documents in Alkermes' quality systems such as change controls, deviations, supplier non-conformances, standard operating procedures, and specifications.

MAJOR RESPONSIBILITIES

• Review documentation such as Certificate of Analyses, assign expiration and retest dates for incoming raw materials
• Coordinate the sampling of all incoming raw materials and components
• Perform the visual inspection and dimensional testing of components
• Identify non-conforming materials at any point in the process
• Coordinate retain program
• Prepare and maintain retain samples for raw materials
• Receive and maintain finished product retain samples
• Review work of peers, as needed
• Create and revise standard operating procedures, technical reports, and specifications, as required
• Write material non-conformances
• Write change controls
• Create discrepancy reports and perform Root Cause Analyses
• Train other colleagues in methods and procedures
• Leads project improvements
• Participates in regulatory and internal audits
• Works in a safe compliant manner
• Use electronic document, inventory and maintenance systems

SKILLS/ABILITIES:

• Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts.
• Able to handle multiple projects with competing priorities.
• Intermediate skills in computer use with ability to learn and master new computer applications.
• Self-directed and motivated, detail oriented, quality-minded with strong organizational skills.
• Effective oral and written communication skills
• Able to follow written procedures and exhibit excellent documentation practices.
• Able to take on additional tasks, as required.
• Able to lift 50lbs
• Work well independently or with a group
• Able to work safely; seek out and encourage safe practices
• Able to pass an eye exam for visual inspection

EDUCATION AND EXPERIENCE:

Bachelor's degree in a scientific discipline with 0-2 years' experience in a quality department

Or

Associate Degree in a scientific discipline with 5+ years' experience in quality department

Or

10+ years' experience in a quality department

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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.