Documentation Specialist
Quality Agents, Rockville, MD, United States
Job Title
Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation specialists will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The document control specialist provide documentation control support for our clients' quality assurance department.
Responsibilities
File, scan and organize Quality Assurance, Validation and Facilities documents
Provide support for any documentation control compliance issues
Ensure procedures are in place and maintained properly as per GMP
Provide improvements to current Quality Assurance documentation control program
Assist Client personnel with maintaining GMP documentation
Work closely with Quality and Facilities to address any documentation discrepancies
Skill Level and Requirements
Experience with filing, scanning, and organizing GMP documentation
Experience with an electronic document management system
Experience with Microsoft Office and Adobe Acrobat
Good communication skills
Minimum Requirements
Bachelor of Science in one of the life sciences
1-2 years of direct experience and/or training in a regulated environment in Quality Assurance, Quality Control, Compliance, or Manufacturing
GMP compliance knowledge
Current driver's license and auto insurance
Benefits
Health, dental and vision insurance
Life, AD&D and Disability Insurance
Health savings account for participants in our health plan
401k retirement plan
Paid time off
Paid holidays
Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.
Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation specialists will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The document control specialist provide documentation control support for our clients' quality assurance department.
Responsibilities
File, scan and organize Quality Assurance, Validation and Facilities documents
Provide support for any documentation control compliance issues
Ensure procedures are in place and maintained properly as per GMP
Provide improvements to current Quality Assurance documentation control program
Assist Client personnel with maintaining GMP documentation
Work closely with Quality and Facilities to address any documentation discrepancies
Skill Level and Requirements
Experience with filing, scanning, and organizing GMP documentation
Experience with an electronic document management system
Experience with Microsoft Office and Adobe Acrobat
Good communication skills
Minimum Requirements
Bachelor of Science in one of the life sciences
1-2 years of direct experience and/or training in a regulated environment in Quality Assurance, Quality Control, Compliance, or Manufacturing
GMP compliance knowledge
Current driver's license and auto insurance
Benefits
Health, dental and vision insurance
Life, AD&D and Disability Insurance
Health savings account for participants in our health plan
401k retirement plan
Paid time off
Paid holidays
Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.