What are the responsibilities and job description for the Document Control Specialist - NP position at LanceSoft, Inc.?
SUMMARY OF FUNCTIONS:
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.
Qualification:
HS Diploma/Equivalent and a minimum of 1 - 2 years of related experience.
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.
Qualification:
HS Diploma/Equivalent and a minimum of 1 - 2 years of related experience.
Salary : $16
