Job Description:

• The Training & Development Associate Specialist is responsible for the successful implementation of the site Manufacturing Training Program.

• They assist in determining training solutions that adhere to the Site Training Program.

• This position trains other staff members, as well as assesses their ability to perform tasks proficiently.

• This position may also perform cleanroom processing duties as a Manufacturing Associate as needed.

REQUIRED COMPETENCIES: 

Knowledge, Skills, and Abilities:

• Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.

• Intermediate sills in design, development, and implementation of training.

• Advanced skills in using Microsoft Word, PowerPoint and Excel.

• Requires a high level of organizational and time management skills.

• Ability to communicate information clearly to facilitate effective learning.

• This position requires speaking in classroom settings.

• Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts.

• Ability to work in an aseptic environment requiring successful completion of qualification program.

Education and Experience:  

• Preferred B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline.

• 1-3 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.

DUTIES AND RESPONSIBILITIES:

• Implements training programs that meet regulatory requirements & business needs including:

• Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.

• Works with the Manager on an on-going basis to implement training goals and meet KPI’s.

• Conducts ILT and OJT sessions to ensure cleanroom operators are proficient.

• Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.

• Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.

• Collaborates with the Manager to ensure training is compliant and effective.

• Maintains accurate training documentation and employee record keeping.

• Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.

• Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.

• Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.

• Develops / implements new course content as procedures change or as new techniques are introduced.

• Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.

• Implements the local Manufacturing Operations new hire Training Program including:

• Promotes and exhibit core Client values in onboarding and training activities.

• Develops an on-the-job training schedule that accommodates individuals of various levels of experience and follows all regulatory and technical requirements.

• Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.

• Conducts ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training.

• Communicates with different departments to ensure new hires have access to all necessary systems and security.

• Maintains the training status of new hires and communicates progress to Department Management.

• Maintain the Training Laboratory and equipment for cleanliness and compliance.

• Complete room activity, maintenance, cleaning, and equipment usage logs (as required).

• Run daily calibration checks on equipment where appropriate and escalate deviations.

• Perform routine cleaning of laboratory areas and equipment.

• Ensure sufficient laboratory supplies for daily training activities.

• Manufacture clinical grade cellular therapeutic products to supply the Clinical Program (as needed):

• Execute/Implement batch records in ISO 7 & 8 clean room environments.

• Observe, practice, and promote all aspects of the GMP & GDP requirements.

• Complete and maintain aseptic processing and sterile gowning qualifications.

• Communicate with Quality Control to ensure proper handoff of process samples.

• Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.

• Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.

• Reports and initiates non-conformances and participates in follow up investigation when necessary.

• Performs all other duties as required.

WORKING CONDITIONS (US Only):

• Ability to perform frequent physical tasks with strength and mobility.

• Daily tasks call for extensive walking, standing and occasional lifting of heavy materials.

• Frequent visual demands require macroscopic and microscopic observations.

• Employees must work in areas where posted Universal Precautions must be observed and practiced.

• Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.

• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

• There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.

• Employees holding this position will be required to perform any other job-related duties as requested by management.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Sufiyan Sheth

Email ID: sufiyans@askconsulting.com

Phone: (470)-730-2993