Summary of Position:
The Document Specialist will be involved in the preparation and review of documents. This position will work with QA on resolution of deviations, out of specifications, training and general manufacturing compliance.
Revise SOPs, batch records and solution records as needed.
Review executed batch records for completeness and working with QA and the manufacturing group to resolve deviations.
Collaborate with QA and manufacturing in performing investigations and will be responsible for writing investigative reports.
Work with QA to ensure manufacturing compliance with GMPs.
Update logs, databases and catalogues.
Maintain documentation files.
Create status reports.
Performs other additional job related duties as required.
The ability to write SOPs, deviations, CAPAs, and batch records.
Strong communication and organizational skills.
The ability to work independently and as part of a team.
Bachelor’s degree in Biological science, or related discipline or equivalent certificate program.
Minimum 2 years experience in Biotech/Pharma industry.
Minimum 2 years experience in biotechnology cGMP manufacturing.