Alkermes plcis 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 addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered inDublin, Ireland,Alkermes plchas an R&D center inWaltham, Massachusetts; a research and manufacturing facility in Athlone,Ireland; and a manufacturing facility inWilmington, Ohio. For more information, please visit Alkermes'website at.
This position will support the OSD commercial manufacturing process in Wilmington. Collaborate with production personnel to ensure documents and production records are kept in compliance with GMP. Ensures the manufacturing systems and documents are GMP compliant and audit and inspection ready. Develop and maintain current regulatory knowledge and keep abreast of procedures and changes. Establishes and maintaining GMP compliant manufacturing procedures and documents. Track OSD product status and informational documents appropriately.
Work with Solid Oral Dose team to proactively identify and resolve GMP non-compliance issues in the Manufacturing group (Materials, Engineering, Production).
Write or revise (as required) SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
Coordinate (expedite when required) the approval process for GMP documentation between Manufacturing, QA, QC, and Development.
Review completed GMP documentation to assure it is complete and accurate in preparation for product release.
Assure the resolution of deviation corrective actions, action items from Change Control systems, as well any audit non-compliance items.
Participate in audits by internal as well as external groups and agencies.
Provide support in document preparation related to regulatory filings, validations, and new product introduction.
Interact with Manufacturing, QA, QC and Material Management staff to coordinate and communicate production requirements.
Develop and maintain (track) OSD production Quality and Documentation metrics through use of analytical tools.
Required Education and Experience
Bachelor's degree in a scientific discipline or equivalent experience
Minimum 3 years' experience in Quality Assurance or manufacturing in the pharmaceutical or medical device industry
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.
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.