Manufacturing Compliance Specialist, Bulk 9/20/2017
JOB DESCRIPTIONAPPLY 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 Manufacturing Compliance Specialist, Bulk 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 position will support the Vivitrol 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. Operate within the product value stream process to include coordination of commercial Vivitrol manufacturing, filling & release. Track Vivitrol product status and informational documents appropriately. Provide project leadership and participation on cross departmental initiatives involving processes, systems, and new approaches to previously existing practices and procedures. Other tasks as assigned by Supervisor.
* Collaborate with Supervisors to proactively identify and resolve GMP non-compliance issues in the Manufacturing group.
* Write or revise (as required) SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing and support department personnel.
* Coordinate (expedite when required) the approval process for GMP documentation between Manufacturing, QA, Validation, and Other Department as necessary.
* Review completed GMP documentation to assure it is complete and accurate in preparation for product release.
* Working in conjunction with Quality Assurance to establish an ongoing program of continuous improvement related to quality, compliance as well as system efficiency.
* Assure the resolution of deviation corrective actions, action items from Change Control systems, as well any audit non-compliance items.
* Conduct informal audits as requested by Management in support of investigations, process failures and routine compliance checks.
* Establish a familiarity with all manufacturing activities involved in the production process in order to share best practices and streamline operations.
* Interact with Manufacturing, QA, QC and Material Management staff to coordinate and communicate production scheduling.
* Develop and maintain (track) product production metrics through use of analytical tools.
* Work on project teams to support manufacturing projects as assigned by leadership.
Minimum Education & Experience Requirements:
* Bachelor Degree in a scientific discipline or equivalent experience.
* Minimum 3 years experience in Quality Assurance, Manufacturing or equivalent experience in the pharmaceutical or medical device industry.
* Ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlines.
* Ability to work cross-functionally to meet company objectives.
* Strong knowledge of pharmaceutical manufacturing processes.
* Working knowledge of Good Manufacturing Practices (US and EU).
* Strong oral and written communication skills.
* Ability to quickly understand detailed and complex processes.
* Excellent organizational and administrative skills.
* Ability to self-manage and prioritize work load.
* Working knowledge of the tools and vocabulary of project management (e.g., GANTT charts, PERT charts, MS Project summary tables and reports).
* Computer proficiency with SAP, Microsoft Project, Word, PowerPoint, Excel
* Advanced understanding of manufacturing process
Personal Attributes Needed:
* Team player committed to quality and working effectively with others both internal and external to Alkermes
* Motivated self-starter.
* Detail and results oriented.
* Dependable, well-organized.
* Efficient with strong communication skills
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.