Alcami Corporation
Technical Trainer - GMP
Alcami Corporation, Charleston, South Carolina, United States, 29408
Free Healthcare Option | Bonus Program | 401(k) with Match | College Loan ForgivenessCore Values: Trustworthy, Relentless, Accountable, Collaborative, Customer-Focused, and SkilledAt Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.Are you interested in joining our team?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 experience2+ 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.About Us:Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.Diversity and Inclusion:Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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 experience2+ 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.About Us:Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.Diversity and Inclusion:Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.