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Site Administrator and Records Manager

2 months ago

Trenton, New Jersey, United States Smithers Full time
Job Summary

Smithers PDS LLC, a leading pharmaceutical development services company, is seeking a highly organized and detail-oriented Archivist and Document Control Specialist to join our team at our Ewing, NJ site.

Key Responsibilities:
  • Records Management: Provide comprehensive records management and documentation support to departments requiring records storage and support.
  • Archiving: Manage archives for GLP study-related documentation, coordinate long-term archiving with external facilities, and retrieve documents as needed.
  • SOP Maintenance: Maintain the standard operating procedure (SOP) system, including administration, tracking, issuing, distributing, formatting, and archiving of SOPs and associated controlled documents.
  • Database Management: Maintain databases, such as deviations, methods, notebooks, training records, and provide monthly metrics.
  • Safety Program: Participate in the safety program to administer the company safety program, ensuring the safety and welfare of staff.
  • Training and Development: Support the creation of new hire training binders and training records.
  • Client Support: Assist with coordination of client visits, including travel arrangements, scheduling of conference rooms, greeting visitors, and arranging meals.
  • Administrative Support: Assist site executives with coordination of meetings, travel arrangements, and other activities as needed.
Additional Responsibilities:
  • Phone Coverage: Provide assistance with phone coverage for the main line.
  • Problem-Solving: Recognize problems and notify management of resolution for issues within scope of responsibility and expertise.
  • SOP Writing and Review: Write and review SOPs and policies/procedures for archiving activities.
  • Training Coordination: Coordinate and schedule departmental training sessions and prepare training materials.
  • New Hire Support: Support and participate in new hire pre-boarding and on-boarding processes.
  • Office Supplies: Monitor office supplies and place orders when necessary.
  • Vendor Management: Receive POs after material receipt is confirmed and work with accounts payable to ensure vendors receive proper payment.
  • Visitor Communication: Communicate the arrival of onsite visitors to relevant staff for both expected and unexpected vendor/client events.
  • Receiving Goods: Assist as a backup for receiving both goods and services through the backdoor entrance.
Requirements:
  • Education: BS or BA in a related field or high school diploma with 5 years of related experience.
  • Knowledge: Knowledge of GLP regulations or toxicology/life sciences.
  • Skills: Proficiency in MS Office Suite, email applications, the use of databases, and Internet searches.
  • Experience: Previous experience in archives, quality assurance, and/or standard operating procedure maintenance is desired.
  • Leadership and Communication: Exceptional organizational and recordkeeping skills, demonstrated leadership and communication skills, and attention to detail.