Integrated Resources
Senior Specialist - Document Control
Integrated Resources, New Brunswick, New Jersey, us, 08933
Overview
Job Title:
Senior Specialist - Document Control
Location:
New Brunswick, NJ 08903 (Hybrid 50% onsite)
Duration:
6+ months (possibility of extension)
Pay rate:
$54 - $56/hr. on W2
Work schedule:
Hybrid 50% onsite Job summary
The Sr. Specialist, Document Control will be responsible for executing the initiation, processing, routing, and archiving of cGMP records related to global specifications and methods. This position supports the Analytical Science & Technology - Global Testing Standard team and reports to the Senior Manager. Job responsibilities Execute the initiation, processing, routing, and archiving of cGMP documentation related to global specifications and methods. Manage and update commercial specifications and methods (internal release, stability, regulatory, and compendial), and supporting documents for all drug products, drug substances, intermediates, starting materials, excipients, reagents, and packaging components. Review and execute change actions for Global Testing Standard documents. Ensure alignment of department procedures with global and site policies and procedures.
Qualifications and education requirements
Bachelors degree in science, engineering, biochemistry, or a related discipline preferred. Minimum 4 years of relevant experience, with direct document management experience in a regulated environment focused on product quality preferred. Strong teamwork, time management, organizational and communication skills. Ability to follow written and verbal instructions. Excellent computer skills, including proficiency in MS Office and document management systems. Detail-oriented with a strong quality mindset. Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS) in a relevant industry. Experience providing guidance on compliance-related issues.
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Job Title:
Senior Specialist - Document Control
Location:
New Brunswick, NJ 08903 (Hybrid 50% onsite)
Duration:
6+ months (possibility of extension)
Pay rate:
$54 - $56/hr. on W2
Work schedule:
Hybrid 50% onsite Job summary
The Sr. Specialist, Document Control will be responsible for executing the initiation, processing, routing, and archiving of cGMP records related to global specifications and methods. This position supports the Analytical Science & Technology - Global Testing Standard team and reports to the Senior Manager. Job responsibilities Execute the initiation, processing, routing, and archiving of cGMP documentation related to global specifications and methods. Manage and update commercial specifications and methods (internal release, stability, regulatory, and compendial), and supporting documents for all drug products, drug substances, intermediates, starting materials, excipients, reagents, and packaging components. Review and execute change actions for Global Testing Standard documents. Ensure alignment of department procedures with global and site policies and procedures.
Qualifications and education requirements
Bachelors degree in science, engineering, biochemistry, or a related discipline preferred. Minimum 4 years of relevant experience, with direct document management experience in a regulated environment focused on product quality preferred. Strong teamwork, time management, organizational and communication skills. Ability to follow written and verbal instructions. Excellent computer skills, including proficiency in MS Office and document management systems. Detail-oriented with a strong quality mindset. Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS) in a relevant industry. Experience providing guidance on compliance-related issues.
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