Document Control Analyst
- Reputable manufacturer of specialty health products who are industry leaders in setting and adhering to high standards in manufacturing and quality control.
- Company focuses on researching and developing products to promote consumer health and is highly regarded in the industry for their advancements in the medical space.
SCOPE OF THE ROLE:
· Provide assistance with maintaining GMP documentation system.
· Assist in implementing information systems for managing document tracking, controlled document distribution (issuance) and records management.
· Oversee the issuance and maintenance of logbooks.
· Facilitate the final review of production batch records.
· Assist in administering the change control system (issuance, tracking, and implementation).
· Consult with other QA and site personnel to ensure timely issuance and execution of records in the quality systems.
· Maintain accurate records for the location of records generated by quality systems.
· Follow all applicable SOPs, policies and other guiding documents that describe document lifecycle management.
· This position will be closely associated and work with the following:
· Operation Management and Personnel
· Quality Assurance Management for multiple locations
· Quality Assurance Technicians, Generalists, Specialists, and Engineers (SC and MD)
· Safety, Security and Environmental Services Manager
· Human Resources
· Regulatory Affairs
· Perform other assigned duties as may be required in meeting company objectives
· Communicate effectively with other departments within the organization and function within a team environment.
- 1+ years of experience in a GMP or pharmaceutical manufacturing environment, preferably in a QA setting.
- B.A or B.S in Science or Technical Field preferred, but not required (with considerable experience in QA)
- Must be detailed oriented and possess strong organization skills with the ability to handle multiple projects.
- Strong written and verbal communication skills required.
- Must be proficient in MS Office Suite.