Quality - DOCUMENT SPECIALIST DOCUMENT SPECIALIST
Company: On-Board Companies
Location: New Brunswick
Posted on: May 28, 2023
On-Board Services is hiring a Documentation Specialist, Quality in New Brunswick, NJ!
For immediate consideration please send your resume to email@example.com
Subject Line: Position Title and State you are Located
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Type: Contract
Job Location: New Brunswick, NJ
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation: $25.00 - $29.00/ Hour
Job Description: Senior Specialist, Documentation Management
This role is 100% Onsite and a 6 month assignment
Work Schedule: Mon - Fri, Business Hours
PDQ Functional Area Description:
PDQ Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.
Key responsibilities include:
---Drug substance and drug product batch disposition (release/reject decision), product certification and release by
the EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors, as
well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency i
Principal Objective of the Position:
---Ensure compliance within the organization as it pertains to documentation and records management
---Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. DocMan)
and Client Records Management Systems
---Generate metrics and support communication (i.e. upcoming periodic reviews, schedule for off-site storage
Key Responsibilities and Major Duties:
---Manages day-to-day operation and compliance of the Summit Records Center, including issuance, archival,
charge-outs, and reconciliation of GxP physical records including but not limited to equipment logbooks,
laboratory notebooks, manufacturing batch records, and equipment qualification records. Coordinates offsite
record storage and recall activities with Iron Mountain.
---Serves as Records Management System (RMS/Celdox) Subject-Matter-Expert (SME) to enable successful
execution of workflows within the system. Identifies opportunities for continuous improvement including need
for system enhancements through partnership with Global Quality Systems and Information Technology.
---Supports implementation of global quality system initiatives, including but not limited to electronic
documentation systems and processes.
---Utilize the Electronic Document Management System (EDMS) to manage hardcopy GMP documents submitted
for retention and archival.
---Provide support for procedural documentation requests, records management, issuance of logbooks/notebooks
issuance, tracking and reconciliation for the NBR site.
---Completes routine tasks with little or no supervision.
---Requires moderate direction to complete more complex tasks
---Adherence to Client core behaviors
---Adherence to Client core behaviors
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Additional Job Requirements:
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
Keywords: On-Board Companies, New Brunswick , Quality - DOCUMENT SPECIALIST DOCUMENT SPECIALIST, Other , New Brunswick, New Jersey
here to apply!