Please note that this is a 12 Month Contract position and is On-Site. GMP experience is required. No H-1B or Corp to Corp.
TOP SKILLS:
- Issuing documents/labels, reconciling, and managing the Document Management System (TMS).
- GMP experience is required.
QUALIFICATIONS:
High school diploma or equivalent.
Prior experience working in a GMP production environment.
Knowledge of GMP guidelines and International Council for Harmonisation (ICH) regulations related to the production of APIs and drug products.
Strong written and verbal communication skills.
Excellent attention to detail, organizational skills, and ability to manage multiple tasks.
Ability to manage controlled documentation and ensure documents are prepared on time and maintained according to procedures.
Ability to use, maintain, and provide training on a Training and Document Management System (TMS).
Ability to present information effectively and respond to questions from co-workers, managers, contractors, and customers.
Experience managing projects and identifying opportunities for process improvement.
PREFERRED SKILLS:
Experience in document control within a pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environment.
Experience issuing and reconciling controlled documents, including logbooks, notebooks, controlled forms, batch records, and protocols.
Experience with document lifecycle management, document archiving, and controlled labeling materials.
Experience training employees on document management systems and related procedures.
Proficiency in Microsoft Word, Access, Excel, and Internet applications.
JOB DESCRIPTION:
POSITION SUMMARY:
The Document Control II will support Agilent's operations in Frederick, CO, by managing controlled documentation, issuing and reconciling documents and labels, and maintaining the site's Training and Document Management System (TMS). This role involves a variety of daily responsibilities, including document issuance, reconciliation, labeling, and document lifecycle management, while ensuring compliance with applicable procedures and GMP requirements.
KEY RESPONSIBILITIES:
Document Control and Reconciliation
Maintain all document files related to Agilent NASD.
Assist with archiving documents at the offsite storage location.
Issue and reconcile controlled documentation, including logbooks, notebooks, controlled forms, batch records, and protocols.
Ensure controlled documents are prepared on time and managed according to established procedures.
Document Management System (TMS)
Manage the document lifecycle using the site's Training and Document Management System (TMS).
Maintain and support the use of TMS and related document management processes.
Provide training to Agilent personnel on TMS and associated procedures.
Labeling and Documentation
Generate, review, and approve labeling materials.
Ensure controlled documentation and labeling materials are accurate and compliant with applicable requirements.
Coordinate document issuance and reconciliation to support daily operations.
Compliance and Cross-Functional Collaboration
Represent Document Control in internal meetings, customer interactions, and regulatory inspections.
Support compliance with GMP guidelines and applicable ICH regulations.
Respond to questions from co-workers, managers, contractors, and customers regarding document control processes.
Provide support for additional projects and tasks assigned by the Document Control Supervisor.
Process Improvement
Evaluate existing processes and identify opportunities to improve efficiency.
Help implement process improvements and promote consistent document control practices.
Manage multiple tasks and priorities while maintaining accuracy and meeting deadlines.
SUCCESS MEASURES:
Maintain accurate and organized controlled documentation.
Issue and reconcile documents and labeling materials accurately and on time.
Ensure proper management of the document lifecycle within TMS.
Support compliance with GMP requirements and established procedures.
Provide effective TMS training and support to Agilent personnel.
Identify opportunities to improve document control processes and operational efficiency.
Candidates must provide their phone number. Job reference number is A5611.
