• Job Description

  Req#: 25-227537
  Enter Job Description...
  This position is responsible for maintaining records and operating document control systems to ensure compliance with FDA Current Good Manufacturing Practices (cGMP), OSHA, EPA, DEA, and AMRI policies and procedures. As well, the incumbent provides support at the main reception desk, providing a presence and pleasant greeting for visitors (customers, regulators, corporate visitors, new employees, etc.), and processing visitors in a timely and efficient fashion.
  MAJOR DUTIES AND RESPONSIBILITIES include the following and other duties as assigned.
  Key Job Responsibilities:
  • Coordinate site wide document control systems and processes to ensure their integrity and compliance with regulations. (FDA, OSHA, EPA, DEA, and AMRI policies and procedures). Examples include:
  · QC records (raw material, intermediate, finished product releases).
  · Test methods, specifications, validation protocols, and all report.
  · QC calibration and qualification documents.
  • Ensure that documentation/records are indexed, filed, archived, retrievable and issued, consistent with AMRI procedures and policies.
  • Maintain an organized filing system for both hard copies and electronic files including onsite and offsite archiving program.
  • Maintain training records utilizing Learning Management System.
  • Provide administrative support to various site departments to help streamline processes for efficiency and effectiveness. QA/QC, Human Resources, Maintenance, Accounts Payable.
  • Provides logistics support for customer and regulatory audits; meetings; plant meetings & events. May include travel arrangements, meals, lodging, etc...
  • Manage calendars & schedules for Site Lead Team members.
  • Other duties as assigned by the site management team.
  Qualifications:
  • Minimum 2 year’s experience in previous administrative role.
  • Previous experience with SAP highly preferred Strong attention to detail and self-checking skills
  • Good communication and time management are required.
  • Pleasant outward demeanor to greet and process visitors at the site.
  • Previous experience working with a Learning Management System
  • Demonstrated experience working with and managing confidential information.
  
  EEO Employer
  LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
  This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

• About the company

  Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.

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