Training Specialist

Training Specialist

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Training Specialist is responsible for increasing productivity by teaching new skills and knowledge to employees. The Training Specialist will use adult learning theory through classroom training seminars, training in a lab environment and exercises to enhance learning. Responsible for scheduling/coordination and documentation of the training and training activities.

This role is responsible for establishing and maintaining the GMP training program to ensure compliance with quality systems and current Good Manufacturing Practices (cGMPs) processes and procedures in support of the biologics industry. Responsible for training employees on the following topics: GMP, GXP, Aseptic Technique, Advanced Aseptic, Aseptic Gowning and technique, Gown qualifications, Sterility Assurance courses, lab courses, etc. at the Swiftwater site to ensure employees have the appropriate skills to perform tasks and processes in a regulatory environment and to meet regulatory requirements.

Training Specialist will need to maintain Gowning Qualification yearly. The Training Specialist will incorporate the appropriate levels of evaluation and skill check and measurements to verify the learner has the knowledge required to transfer to the workplace. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Main Responsibilities:

Developing and implementing annual training programs to ensure compliance with Good Manufacturing Practices (GMP) and company standards

Collaborating with department heads to identify training needs and developing customized training plans

Supporting the managers in the establishment of the curricula for the different areas

Developing training materials with the support of the relevant subject matter expert to address the training needs and plans

Conducting training sessions for new hires and existing employees on specific topics

Monitoring the completion of the training plan to identify risks and weaknesses

Evaluating training effectiveness through assessments, feedback, and performance metrics

Support Subject Matter Expert in updating training materials to reflect changes in regulations, procedures and best practices

Leading continuous improvement initiatives to enhance training material and processes

Providing support during regulatory inspections and audits by presenting training records and training process and material

The Training Specialist will:

Be responsible for training topics to New Employee Onboarding (NEO) as well as Aseptic Related trainings (EM, Aseptic Technique, Gowning, Advanced Aseptic Technique, etc...)

Understand adult learning theory and applying this to classroom training

Train in classroom as well as lab environments

Facilitate the transfer of learning to adults through engaging tools and instruction

Provide trainings as needed to meet site and regulatory requirements

Developing and implementing annual training programs to ensure compliance with Good Manufacturing Practices (GMP) and company standards

About You

Basic Qualifications:

This position supports 1st shift. However, the Training Specialist must be flexible to deliver training to the 2nd and 3rd shifts trainees, as needed for business continuity

3-5 years of experience in Pharmaceutical/FDA-regulated environment

Experience and knowledge in Aseptic/Gowning/Environmental Monitoring/GMP, etc. processes required for Class A/B and C/D rooms

Experience in evaluating and measurement of employee training and transfer of learning.

Ability to embed Adult Learning Theory in training and education

Trainer must be OR be able to become Aseptic Gown trained and Qualified to train others and must maintain this status yearly

High school diploma or equivalent required.

Preferred Qualifications:

BA/BS degree in the Scientific field or Training

Sterility Assurance (SA) knowledge

Aseptic gown qualified

Aseptic Technique qualified

Advanced Aseptic Technique qualified

EM qualified

Qualified Trainer

Expected Experience:

Experience in quality management systems in the pharmaceutical industry ensuring compliance with GMP and other regulatory standards and experience in developing, implementing, and evaluating training programs, particularly those related to quality systems and regulatory compliance.

Expected Technical skills:

Ability to create effective training programs and materials that meet the needs of the organization and comply with regulatory standards

Proficiency in evaluating training effectiveness through data analysis, assessments, and feedback to continuously improve training programs

Strong understanding of regulatory requirements and the ability to ensure training programs align with these standards

Expertise in planning, organizing, and managing training projects, including setting timelines, allocating resources, and monitoring progress

Excellent verbal and written communication skills, with the ability to effectively convey information, collaborate with various departments, and present training outcomes to senior management

Key involvement in Decision Making process:

Key roles (D,A,I)

Establish and prioritize training objectives for the site (D)

Advise department heads on training needs (A)

Decide on training content and delivery methods (D)

Advise on improvements based on training evaluations (A)

Advise on continuous improvement initiatives (A)

Language: English

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.