Senior Specialist, Document Control

1 month ago

New Brunswick, United States Pyramid Consulting, Inc Full time

Immediate need for a talented Senior Specialist, Document Control. This is a 12+months contract opportunity with long-term potential and is located in New Brunswick, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.


Job ID:24-35830

Pay Range: $60 - $67/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).


Key Responsibilities:


  • Implements training programs that meet regulatory requirements & business needs.
  • Provide training expertise and consultation in support of the Devens site training model and process.
  • Works with L&D and functional Subject Matter Experts 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 support functional unit training requirements.
  • 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 L&D team and functional SMEs 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.
  • Promotes and exhibit core Client values in onboarding and training activities.
  • Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
  • Communicates with different departments to ensure new hires have access to all necessary systems and security.
  • Observe, practice, and promote all aspects of the GMP & GDP requirements.
  • 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.


Key Requirements and Technology Experience:


  • Requires understanding of GMP manufacturing environments, processes and controls requirements.
  • Intermediate sills in design, development, and implementation of training, utilizing ADDIE instructional design model.
  • High level of experience delivering and assessing 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.
  • Bachelor degree in Business or Education, B.S. in Biology, Biochemical, Chemical, or 3-5 years of relevant experience in a GMP manufacturing environment.


Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.


Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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