- Posted: over a month ago
Title: Project Coordinator
Location: West Point, PA
Duration: 12+ Months
Qualifications:Education: BS/BA or appropriate combination of education and relevant practical experience Qualifications: Working knowledge of Packaging Operations and related work centers. Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution. Strong attention to detail. Strong verbal and written communication skills. Strong organizational skills, ability to prioritize and ability to multi-task. Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint).
Responsibilities:Summary: Team member will be responsible to read, comprehend, and translate clinical trial protocols /packaging specifications into clinical label generation software. Individual will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the Client label systems. Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs. Primary activities: 1. Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP’s and appropriate Client safety requirements to meet exacting standards defined by Client, the FDA and EU or other international regulatory agencies. 2. May be responsible for any or all of the following: - Coordination of Translation Requests - Generation of Clinical Label Proofs with CLPG - Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements, etc. - Maintain Label Translations library - Interpret clinical study design and Clinical Supply Strategy (CSS) - Design and verify label models - Coordinate MLBL manufacturing at vendors - Perform visual inspection and accountability for label proofs, clinical labels and RCE’s 2. Provide detailed analysis of issues and collaborate for creative problem solving 3. Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders. 4. May represent Clinical Packaging on internal or cross-functional teams. Will undertake specific projects within the group on as needed basis 5. Participate as necessary in complaint and deviation investigations with a focus on true root cause, and creation of appropriate Corrective and Preventative actions (CAPA's). Drive CAPA's to closure. 6. Train and remain proficient in appropriate systems and software 7. Responsible for the physical facility and good housekeeping practices within their area.
Pyramid ConsultingWhy Work Here?
Pyramid Consulting, Inc. provides Staffing and Technology Solution services to Fortune 500 and 1000 companies across the USA and Canada.
We place top talent through our divisions: Technology, Staffing, Professionals, Talent Digitalization, and Pyramid Academy. Our flexible staffing options include contract, contract-to-hire, direct hire, and SOW/Statement of Work. We deliver top talent to our clients by combining the use of the latest technology with the subject-matter expertise that our seasoned team of recruiters brings to the process. With the integration of smart sourcing tools, machine learning, and AI/Artificial Intelligence into our screening process across the organization; we evaluate a large volume of candidates to find the most suitable talent.
AddressWest Point, PA
TechnologyView all jobs at Pyramid Consulting