ACS group has an immediate need for a "Specialist Training Development" with experience in the Pharmaceutical Industry. This is a 24- month contract opportunity in Summit, NJ. Our client is a leading Pharmaceutical company.
Please review the job description below:
Top Skills:
Key Requirements and Technology Experience:
Second Shift Onsite Position Duration:24 months
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.
REQUIRED COMPETENCIES:
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: * 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.
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 KPIs.
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 Celgene 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 participate in follow up investigation when necessary.
Performs all other duties as required.
Additional Skills: Aseptic technique.
Thanks & Regards
Parag PATEL
Team Recruitment
P: (+1)
678 487 8366
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
Recent Awards and Recognitions:
IT and Industry certifications:
Resolve Issue
Provide Direction
Provide Actionable Feedback
Training
Advising
Please review the job description below:
Top Skills:
- Training
- Trainer
- Cell therapy
- Pharmaceutical
- Biology
Key Requirements and Technology Experience:
Second Shift Onsite Position Duration:24 months
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.
REQUIRED COMPETENCIES:
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: * 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.
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 KPIs.
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 Celgene 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 participate in follow up investigation when necessary.
Performs all other duties as required.
Additional Skills: Aseptic technique.
Thanks & Regards
Parag PATEL
Team Recruitment
P: (+1)
678 487 8366
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
- Analysts international Corporation (Staff Augmentation Services)
- The Ascent Services Group Inc. (Life Sciences Talent Solutions)
- HireGenics, (Payrolling, IC Compliance, & MSP Services)
- DATA Inc. (Information Technology- staffing)
Recent Awards and Recognitions:
- 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)
- Largest Minority IT Staffing Firm in the US. (SIA 2019)
- ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.
IT and Industry certifications:
- Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data Platform
- AWS Managed Services Partner
- Google Cloud Partner
- ISO 27001:2013 Certified for Data Security
- ISTQB Gold Partner
- ISMS (ISO 27001:2017)
- SOC2 Type II Compliant
Recommended Skills
Time ManagementResolve Issue
Provide Direction
Provide Actionable Feedback
Training
Advising