Documentation Specialist

Alachua, FL, United States
Oct 18, 2019
Required Education
Bachelors Degree
Position Type
Full time
Reporting Relationship

• The Documentation Specialist reports directly to the Manager, Document Control.

Essential Duties and Responsibilities

• Manage and control manufacturing and laboratory documentation, including SOPs, study protocols, study reports, batch production records and other controlled documents

• Edit and format documents for consistency and compliance with applicable department, company, and regulatory standards and circulate them in accordance with established procedures

• Assist in the preparation of regulatory documentation for submissions, including routine correspondence, INDs, BLAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.

• Ensure the proper filing and organization of quality and regulatory documentation

• Coordinate the review and revision of quality and regulatory documentation

• Assign and monitor document numbers and review documents for accuracy and completeness

• Maintain systems for document storage, retrieval and versioning

• Assist with the maintenance of company quality training system

• Support the management of corporate documents as directed

• Other duties as assigned

Educational Qualifications

• Associate's degree and minimum of four (4) years' experience OR Bachelor degree (scientific discipline preferred) and minimum of two (2) years' experience working in a regulated environment

Additional Qualifications

• Experience with document management/records management

• In-depth understanding of GLP, GMP and GCP requirements, guidance documents, systems, processes and procedures

• Strong proficiency in Word, Excel and Adobe Acrobat

• Detail oriented and thorough

• Strong interpersonal skills

• Effective communication skills both verbally and written

Supervisory Skills

• This position does not have supervisory responsibilities