Job # 24282        

Title:  Document Control Supervisor

Location: Waltham, MA

Duration: Direct Hire                                                  

Responsibilities

• Drive, execute and track records and documentation processes throughout the documentation lifecycles.
• Track and maintain other internal records including training, Design History Records, equipment records and laboratory notebooks.
• Assist with the implementation, management and administration of the quality system electronic management systems.
• Work with subject matter experts on technical subjects in a positive, collaborative manner to prepare controlled documents which conform to company defined format.
• Review and proofread documents for consistency of document format and system concerns.
• Verify and issue production documents and product labels to the manufacturing department.
• Assign and track lot numbers, material part numbers, change control numbers, issue numbers, equipment numbers and various other unique tracking identification.
• Provide support for the Quality System during corporate audits.
• Adhere to and enforce company policies and procedures related to document control.
• Perform audits of company areas and processes to confirm compliance with controlled procedures.
• Prepares and processes status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
• Maintains training files and job list for each employee and reports and deviations.
• Provides support on various other projects as necessary, ensuring the precision, accuracy and reliability of the GMP process.
• Maintains the GMP change control program by ensuring completeness of change control documents for accuracy and compliance; establish reporting metrics and provide follow up on implementation plan items for change control closure.

 Requirements

• Experience with Quality System Documentation and good documentation practices.
• 7 to 10 years of Document Control or other Quality Assurance-related experience in a cGMP environment is a plus.
• Experience in the development/implementation of document control and records management procedures in a pharmaceutical or biologics environment.
• Prior experience in GMP-regulated industry is required.
• Knowledge of ISO, FDA and cGMP concepts and guidelines.
• Ability to lead in a management capacity.
• Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
• Work on complex assignments in collaboration with various department system owners.
• Very strong analytical problem solving and organizational ability.
• Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
• Professional, well organized, and eager to learn and be challenged.
• Must have excellent MS Office application Word, Excel, Access, Power Points as well as Adobe Acrobat skills.