- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
- Ability to increase others knowledge of US end European GMP regulations and guidance.
- Strong written and oral communication skills.
- Experience in support of quality systems for drug product manufacturing and quality control operations.
- Strong written and oral communication skills.
- 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.
- Good computer skills.
- Good work ethic, dependable, punctual, and flexible.
- Good motivator of personnel.
- Good team player with a can-do attitude.
- Can get things done on the basis of priority
- Can work in a fast-paced environment with multiple issues open simultaneously.
- Highly organized.
- Attention to detail.
- Identifies opportunities to improve and contributes to problem solving.
- Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others.
- Requires a Bachelor's degree in a scientific discipline or equivalent.
- Minimum of 1 year experience in a Quality Assurance role in the pharmaceutical industry.
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Temp-Training Specialist - Wilmington, United States - Alkermes
Description
Job DescriptionThe Training Coordinator role provides strong administrative support with some operational support for the learning management system (LMS) and processes used for the management of compliance training at Alkermes.
Key Duties
•Administration of the LMS, Docusign system and filing training documents.
•Manage day to day compliance training queries and reports.
•Interface with site and departmental SME's to and assign curricula and associated training items within the Learning Management System (LMS) in accordance with defined processes
•Provide guidance to site and departmental SME's on training systems and processes.
•Support vendor provided compliance related training, ensuring adherence to defined processes
•Review and approve training programs according to approved templates
•Create, edit and maintain training items and completions used for internal and external single use training events
•Generate reports from LMS for compliance status, metrics, and other business requests
•Generate and monitor metrics and key performance indicators to evaluate training assignment effectiveness. Address and/or escalate deficiencies and issues as required.
•Enter annual (comprehensive) curricula review form changes/updates/date completions
•Evaluate system related procedures, work instructions and training manuals for necessary updates
•Provide timely and accurate support for internal audits and third-party regulatory agency inspections
•Identify and lead continuous improvement initiatives to completion, as requested
Skills / Abilities:
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development 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
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.
