Enhances the competencies of individual employees by designing and conducting training programs that boost employee aseptic knowledge and performance in alliance with company's core values. Personnel is responsible for performing training assessments, auditing training files, assisting with the design and delivery of curriculum, and the creation of development plans to ensure employees complete and document training within a designated timeline.
ESSENTIAL DUTIES & RESPONSIBILITIES
Provide leadership to AMA Training Specialists to include coaching, critiquing, and motivating.
Partner with Training Team, Subject Matter Experts and site resources to develop and maintain training content, materials and tools (curricula, OJTs, assessments, trainer guides, evaluations, etc.)
Execute weekly and monthly training reports to drive participation and accountability towards Global and site KPIs and compliancy standards within aseptic operations.
Create and maintain computer-based e-learning modules, skills, and knowledge assessments (IL/OJT) as required to support department learning objectives and training requirements.
Partner with aseptic training team members to implement training system improvement and other change initiatives.
Deliver small or large classroom training with a focus on GMP and aseptic production.
Collaborate with authors and SMEs in aseptic production operations to support instructional design, technical writing, and training development needs; ensure that aseptic production work instructions and training materials are in alignment.
Conduct regular GEMBA walks and observe employees entering aseptic areas and/or performing aseptic activities in order to re-enforce correct gowning and aseptic techniques.
Develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment.
Work cross functionally with Training Department, Manufacturing leadership, and equipment/system/process SMEs to develop and implement course outlines for OJT and IL training.
Onboard new employees and assist with the development and execution of Job Curriculum.
Translate requirements into trainings that will groom employees for the next step of their career path.
Ensure required annual training for employees is completed and documented in a timely fashion.
Acclimate new hires to the business and conduct orientation sessions.
Assist with the updating, auditing, and modification of employee training files.
Consistently evaluate ongoing programs to ensure continuous improvement in regard to aseptic conduct and technique for all Grade A classified environments, with a focus on conduct and technique in open RABs as well as fully enclosed isolator Grade A filling operations.
Perform tasks in Master Control to ensure electronic records align with employee qualifications.
Support GRAM's Core Values of Quality, Service, Collaboration, and Courage.
Support Agency, customer and vendor audits as needed.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Perform all other tasks, projects, and duties as assigned
DESIRED SKILLS & ABILITIES
Strong in building relationships and able to communicate at all levels.
Ability to present complex information to a variety of audiences.
Proven leadership and mentorship skills.
Dynamic and creative.
Working knowledge of spreadsheets, database, and word processing applications.
Excellent oral and written communication skills.
Consistently/Frequently - see (vision), hear, ability to read and write, ability to interpret information, basic math, reading and writing in English.
Proficiency in both written and verbal communication and presentations.
Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Results oriented and efficient.
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
Ability to work closely with a diverse customer base (internally and externally).
Ability to work well in a cross-functional team environment.
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Qualified candidates possess a Bachelor's degree or equivalent training and/or experience with aseptic processes is
necessary. In-depth understanding of aseptic gowning and aseptic processing principals in a pharmaceutical environment.
Aseptic processing certifications desired.
Demonstrated experience with the ADDIE model, or similar training development model preferred.
A minimum of 3 years' experience working directly in Grade A clean-room environments, including isolators, hoods, and/or rooms.
Experience developing, delivering, and assessing classroom, computer-based, and competency based functional training.
Abreast on current industry standards for sterile filling operations (traditional, lyophilized and terminally sterilized products) and environmental/personnel monitoring practices.
GRAM supports Equal Opportunity Employment