Signature Biologics, as part of a suite of emerging biotechnology and research companies, focuses on the development and commercialization of regenerative based products. We have significant clinical experience working with human perinatal biologics internationally and we are currently developing products in the US.

Essential Duties and Responsibilities:The Document Control Specialist II oversees the revision, issuance and tracking of controlled documents used to support Phase I/II/III and commercial GMP manufacture of bulk and sterile fill biologics. The individual is a mature professional capable of working independently and in a team setting. The individual continually evaluates opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards. The individual requires the ability to produce results in a fast-paced environment to meet deadlines and to effectively prioritize responsibilities based on criticality.

Key Responsibilities:

• Manages the eQMS (MasterControl) and the Document Control Storage Room.
• Works directly with the QA department and other departments to revise, issue and track controlled documents to meet timelines.
• Responsible for filing, tracking and archival of GMP documentation.
• Manages Training and Documents in the eQMS (MasterControl).
• Provides reports to Upper Management regarding document status.
• Maintains databases used for tracking various GMP documentation.
• Supports regulatory audits/inspections.
• Works closely with various departments to resolve issues and offer assistance as needed.
• Processes change requests for documents.
• Edits documents in accordance with formatting and template requirements.
• Notifies staff of all recently approved documents and helps departments identify training requirements as necessary.
• Assigns effective dates to approved controlled documents.
• Responsible for processing, distributing, and maintaining controlled documentation (i.e., SOPs, material specification, logbooks, etc.) using a document control system (MasterControl).
• Maintains compliance with all required training and assists with training of the staff.

Education and/or Work Experience Requirements:

• BS/BA in a life science or an equivalent combination of education, experience, and training
• Minimum of 3 years experience working with MasterControl in Biotechnology, Pharmaceutical or Biopharmaceutical industry.
• Strong knowledge of eQMS, Systems and Document Creation.
• Exceptional attention to detail.
• Excellent verbal and written communication skills with the ability to collaborate across multiple teams and projects.
• Ability to multi-task and prioritize responsibilities.
• Expert knowledge of Windows systems (MS Office – Word, Excel, Power Point)
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product.

Physical Requirements:

• Ability to lift 50 lbs.