3443 Document Specialist
Update and route specification documents (URS, FS, DS, etc.).
Update and route lifecycle documents (risk assessments, trace matrices, etc.).
Generate, route, close commissioning protocols and incidents.
Generate, route, close qualification protocols and deviations.
Track and ensure on time completion of deliverables.
Maintain and track all issues.
Collaborate with cross-functional teams to resolve issues.
Attend project meetings and provide status updates to project team.
Adhere to site and global SOPs and Wis.
Understanding of GMP Technical understanding of production areas (upstream/downstream). Understanding of Engineering concepts.
Maintain training qualifications.
Proficient at Microsoft Office Suite.
Experience with Biopharmaceutical manufacturing.
Knowledge of GMP guidelines, experience in generation of controlled documents.
Demonstrate good organizational and time utilization skills.
Demonstrate good written and verbal communication skills.
Ability to work most of the time independently with minimal direct supervision.
Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.
Bachelor’s degree in Engineering or Science preferred.
Minimum of 1 year in the pharmaceutical/biotech industry/GMP experience preferred.