About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:
Position Type:12 month contract with possible extension
Job Location: Summit, NJ
Benefits: 401K, Medical, Dental, Vision, and Life Insurance
Compensation: $45-50.19/hr

Summary:
The Training & Development Specialist is responsible for the successful implementation of the site Manufacturing Training Program. The Specialist assists 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. The Specialist may also perform cleanroom processing duties as a Manufacturing Associate as needed.

Qualifications:

• Required Associate degree or preferred Bachelor's degree
• B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 3-5 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.

Requirements:

• 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.

Duties:

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

o 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.
o Works with the Manager on an on-going basis to implement training goals and meet KPI’s.
o Conducts ILT and OJT sessions to ensure cleanroom operators are proficient.
o Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.
o Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.
o Collaborates with the Manager to ensure training is compliant and effective.
o Maintains accurate training documentation and employee record keeping.
o Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
o Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
o Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
o Develops / implements new course content as procedures change or as new techniques are introduced.
o 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:

o Promotes and exhibit core Client values in onboarding and training activities.
o Develops an on-the-job training schedule that accommodates individuals of various levels of experience and follows all regulatory and technical requirements.
o Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
o Conducts ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training.
o Communicates with different departments to ensure new hires have access to all necessary systems and security.
o Maintains the training status of new hires and communicates progress to Department Management.

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

o Complete room activity, maintenance, cleaning, and equipment usage logs (as required).
o Run daily calibration checks on equipment where appropriate and escalate deviations.
o Perform routine cleaning of laboratory areas and equipment.
o Ensure sufficient laboratory supplies for daily training activities.

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

o Execute/Implement batch records in ISO 7 & 8 clean room environments.
o Observe, practice, and promote all aspects of the GMP & GDP requirements.
o Complete and maintain aseptic processing and sterile gowning qualifications.
o 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.

Additional Job Requirements:

• Position Handles Hazardous Materials
• Position opens for day shift but candidates should be flexible to work 2nd shift if required.

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

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