Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Sr. Quality Engineer

This position supports the Wilmington site Quality Continuous Improvement and Excellence to drive higher standards and maturity in site Quality Culture. The role will require collaborating with and influencing colleagues across the organization to develop, implement, adopt and monitor continuous improvement initiatives. These programs will drive Excellence in Quality through the organization and support the overall Pharmaceutical Quality System. In addition, this role will lead and facilitate complex investigations that deemed critical for Alkermes.

Key Duties:

• Develop, implement and maintain programs which drive higher levels of Quality Culture maturity and Excellence In Quality
• Identify and implement quality process improvements and Pharmaceutical Quality System enhancements through Op Ex Programs
• Collaborate with QC, MSAT, Manufacturing and Validation to monitor performance indicators to ensure the health of Product Quality
• Lead and facilitate complex and/or high profile investigations that deemed critical for Alkermes
• Facilitate Quality Review Board (QRB)
• This position is expected to be flexible in work hours to meet the business needs and may travel a few times per year

Preferred Skills/ Abilities:

• Experience and knowledgeable with Statistical Process Control (SPC), and the application of SPC in trending of product performance
• Thorough understanding of Quality by Design (QbD) concept
• Process validation lifecycle knowledge and experience
• 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 get things done based on influence
• Comfortable workings in a fast-paced environment with multiple issues open simultaneously
• Customer service mindset
• Identifies opportunities to improve and contributes to problem solving
• Experience designing, implementing, delivering and measuring effectiveness of improvements in a GxP environment
• Understanding of the current pharmaceutical industry and applicable domestic and international compliance regulations
• Full understanding of FDA regulations and best practices in GMP environment
• Experience with root cause analysis, risk management, meeting management and excellent documentation skills

Required Education/Experience:

• Bachelor's degree in a scientific discipline or equivalent
• 7-10+ years' experience in the pharmaceutical industry, preferably with parenteral and oral dosage forms in a Quality role

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.

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