QA Documentation Specialist II:
American Gene Technologies (AGT) is a leader in cell and gene therapy of infectious diseases, monogenic diseases, and cancer. Located in Rockville, Maryland, we are expanding the capacity for Research and Development of novel therapies and are seeking a QA Document Control Specialist for our Quality Assurance Team. This group supports AGT’s regulatory and clinical activities. The successful candidate must be skilled and experienced in the practice of quality assurance for Phase I/II Clinical trials for cell and gene therapy products.
- Manages the Document Control and Training Programs.
- Receives, reviews and formats QMS documents for review and approval
- Serves as a Document Control Archivist
- Manages the organization of all QA/QC and research records and reports
- Serves as a local system administrator and primary point of contact for the eDMS, documentation/archival process initiatives and other Quality Software
- Assigns and controls the issuance and use of logbooks and laboratory notebooks.
- Trains various teams on newly revised/effective procedures as well as new team members
- Participates in internal/external audits upon request
- Supports New Hire Orientation training
- Performs other activities to support Quality Assurance functions
Skill, Knowledge and Abilities Required:
- BS degree preferred or equivalent level of skill and experience
- Minimum of 2-4 years of technical writing/document experience in the GMP pharmaceutical/biotechnology discipline.
- Experience with MasterControl/QT9 highly desired and preferred
- Experience drafting technical procedures and documents relating to GMP operations with the following skills:
- Highly organized with strong attention to detail and great technical writing ability.
- Ability to manage time, priorities, and multitask effectively.
- Ability to communicate with internal and external stakeholders effectively at various levels
- Ability to coordinate and lead meetings related to job functions.
- Ability to work well independently and with minimum supervision and identify gaps within documents/ quality processes.
- High level of computer literacy, including MS Applications and Adobe
Working Conditions and/or Physical Requirements:
This is an office role that requires some physical mobility and physical effort. Biohazard precautions are required for working near gene therapy vectors, animal or human blood and tissue, or human pathogens.
The position reports directly to the Quality Assurance Director.
American Gene Technologies (AGT) is an equal opportunity employer and will consider applications without discriminating based on disability, sex or sexual orientation, race or ethnic origin, marital or civil partnership status, or any other characteristic protected by law. AGT employees receive competitive salaries, comprehensive healthcare coverage, paid gym membership, 401K plan with employer contribution, incentive stock options, and annual paid leave.
Job Types: Full-time
Pay: $65,000.00 – $75,000.00 per year
- Dental insurance
- Disability insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
- 8-hour shift
- Day shift
- Onsite COVID testing for employees
- Bachelor’s (Required)
- Technical Writing: 2 years (Preferred)
- Document management: 2 years (Preferred)
- One location