The QA Specialist works with the Director, QA to develop, manage and coordinate the MedSource training program and is responsible for managing, administering, and troubleshooting the Document and Learning Management System.
DUTIES AND RESPONSIBILITIES:
- Works with QA and Training management to develop and implement training initiatives, assess progress, and focus on the continuous improvement of training materials, programs, and processes.
- Ensures that the required technical, developmental, and regulatory training is implemented to achieve compliance, business objectives and development of employees.
- Establish and manage the Learning Management System (LMS) to ensure employee training is appropriately assigned and maintained in a current status.
- Assist with configuration and validation activities for the LMS as well as communication and management activities with the vendor.
- Perform training of personnel as required (i.e. hands-on, Instructor-led, workshops, etc).
- Develop new training procedures and revises existing procedures as required.
- Communicates the requirements for training to staff and provides follow-up.
- Develops and identifies key performance indicators and provides reports to management with training metrics and other training information as required.
- Maintains the training schedules and the training matrix.
- Works closely with management to evaluate and identify training needs and makes recommendations on training material and methodology.
- Establishes and maintain relationships cross functionally.
- Performs all other duties as assigned.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- Bachelor’s degree
- Competency with electronic systems
- 3+ years of experience in QA and/or Training role within a pharmaceutical, biotechnology, or CRO industry and knowledge of the clinical trials process.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Ability to communicate effectively at all levels with internal and external stakeholders.
- Knowledge of FDA regulations and ICH/GCP guidelines preferred.
- Technical abilities and experience with relevant computer systems and applications (Adobe applications, Microsoft Word, Excel and PowerPoint, Document and Learning Management Systems).
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
- Strong leadership skills and the ability to lead through example.
- Strong understanding of clinical trials process with demonstrated ability to have designed and implemented training related programs and initiatives.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Strong problem-solving skills and the ability to think and act strategically, anticipate roadblocks and map out next steps.
- Demonstrated high level of integrity, ethics, and professionalism.
- Excellent written, oral and presentation skills.
CONDITIONS OF EMPLOYMENT:
Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment
MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.