Sr. Specialist, Document Control

Job Title: Sr. Specialist, Document Control
Job Location: New Brunswick, NJ 08903
Job Duration: 12 Months+

Pay range: $54 -$58/hr. on W2

Work Schedule:
Hybrid (50% onsite)

• Week 1: 3 days onsite
• Week 2: 2 days onsite
• Repeats every two weeks (total 5 days onsite and 5 days remote in each 2-week period)

 
Job Description:
Job Summary:
Client is seeking a Sr. Specialist, Documentation Management in New Brunswick, NJ. This individual will be responsible for executing the initiation, processing, routing, and archiving of cGMP records related to global specifications and methods.
The Sr. Specialist, Documentation Management role reports to the Senior Manager, Analytical Science & Technology - Global Testing Standard.
 
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 Client 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:

• Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry, or related discipline, or its equivalent is preferred.
• A minimum of 4 years of relevant experience; direct document management experience in a regulated environment focused on product quality is preferred.
• Strong teamwork, time management, organizational and communication skills, and the ability to follow written and verbal instructions are required.
• Excellent computer skills and knowledge of MS Office and Document Management systems is required.
• Detail-oriented with a quality mindset.
• Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS) in a relevant industry.
• Experience in providing guidance on compliance-related issues.