- 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, Inc.
Description
The TrainingCoordinator role providesstrong administrative support with some operational support forthe 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 reviewform 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:
Personal Attributes:
Education/Experience:
