Technical Trainer - GMP

Job Summary:
The Technical Trainer is accountable for driving results in a fast-paced environment. The Technical Trainer is an experienced learning and development professional with technical training and cGMP expertise.
On-Site Expectations:

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:00am - 4:00pm. May vary based on shift needs.

Responsibilities:

• Creates technical training programs/content according to site/department requirements.
• Works with site management to conduct needs assessments and identify site-specific technical training needs.
• Provides training schedules and agendas.
• Determines course content and objectives.
• Coordinates with internal and external subject matter experts for content development and implementation.
• Prepares training materials and organizes training sessions, in groups or individually.
• Conducts hands-on skills training for technical positions.
• Oversees technical training as part of the quality management system for assigned work groups within Alcami. This may include larger or multiple sites.
• Partners with Department Owners to ensure accurate and relevant assignment of curriculum in the Electronic Document Management System (EDMS) within Alcami.
• Oversees the train-the-trainer certification for assigned groups. Provides coaching for certified trainers.
• Creates reports of training completion status.
• Advocates timely completion of training and adherence to all regulatory compliance requirements.
• Supports and participates in quality, client and regulatory audits as required.
• Completes other project work as required to support changing business requirements and resourcing requirements.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications:

• Bachelor's degree in life science, training and development, or related field required or equivalent experience.
• 5 years of relevant experience including pharmaceutical or CDMO industry experience, preferably sterile fill and finish.
• 2 years of technical training experience
• 2 years of experience advising and influencing internal stakeholders (leadership, technical trainers, etc.)
• 2 years of clean room experience with aseptic behaviors.

Knowledge, Skills, and Abilities:

• Expert knowledge of cGMP and quality management systems.
• General knowledge of instructional design, blended learning and contemporary learning methodologies.
• General working knowledge of MS Word, PowerPoint, Excel, Outlook.
• Awareness of and ability to learn emerging learning technologies.
• Excellent written and verbal communication skills.
• Excellent attention to detail.
• Excellent training and facilitation skills.
• Excellent project management skills.
• Ability to manage multiple priorities.
• Ability to manage, adapt to and influence change in a dynamic, high-pressure environment.
• Ability to coach and influence internal key stakeholders.

Travel Expectations:

• Up to 30% travel expected.

Physical Demands and Work Environment:
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is frequently required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.