Documentation Specialist - Alachua, FL | Biospace
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Documentation Specialist

AGTC

Location:
Alachua, FL
Posted Date:
11/29/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology,

Job Description


Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies with an initial focus on ophthalmology.  AGTC is seeking a highly motivated individual to edit, authorize and manage regulatory and quality documentation that supports product development activities in compliance with cGXP requirements.

Reporting Relationship
•   The Documentation Specialist will report directly to the Senior Director, Regulatory Affairs and will have dotted line reporting to the Director, Quality Assurance.

Essential Duties and Responsibilities
•   Assist in the preparation of regulatory documentation for submissions, including routine correspondence, INDs, BLAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.
•   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 in accordance with established procedures
•   Ensure the proper filing and organization of regulatory and quality documentation
•   Coordinate the review and revision of regulatory and quality documentation
•   Assign and monitor document numbers and review documents for accuracy and completeness

Requirements


•   BS degree (scientific discipline preferred) and 2 to 5 years’ experience working in a GLP/GMP environment, preferably in a biotechnology company
•   Strong proficiency in Word, Excel and Adobe Acrobat
•   Experience with the Common Technical Document (CTD) format
•   Effective communication skills both verbally and written

AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity.  AGTC is an EOE and maintains a drug free workplace.