The Document Control Supervisor is responsible for supporting the internal GLP/GMP auditing program, and assisting in the compilation of regulatory submissions. The candidate will ensure compliance with applicable regulatory requirements by directly working with external manufacturing quality organizations and internal/external partners.
Responsibilities:
Drive, execute and track records and documentation processes throughout the documentation lifecycles including but not limited to:
Generation and control of document change requests
Document formatting and word processing from redlines
Routing, tracking and facilitating timely documentation review, approval and periodic/annual review
Control, distribution and maintenance of internal procedural documentation and records
Indexing, archival and retrieval
Maintenance of product specification files
Maintenance of electronic department directories
Develop and conduct Document Control related training
Creation of Master Batch Records and issuance of Batch Records
Coordinate and compile Batch Record History documents
Release of all raw materials for GMP use and maintain an inventory system
Initiates the creation, review and revision of procedures, specifications and forms
Track and report on document review progress
Track and trend all NCMI’s, Deviations, CAPA’s, and Change Control’s
Assure completeness of all documentation
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 Histogenics 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 any 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 in pharmaceuticals or biologics industries
7 to 10 years of Document Control 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 medical device or other GMP-regulated industry is preferred.
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 applications Word, Excel, Access, Power Point as well as Adobe Acrobat skills.
Candidate must be flexible and able to adapt to changes in priorities.
If applying for this position please include salary requirements along with resume
LOCAL CANDIDATES ONLY
- Location: Waltham, MA
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