Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: Computer System Validation, Data Integrity, GxP Requirements, GAMP, 21 CFR Part 11
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: Raw Materials Testing, cGMP, USP Methods, FDA Guidance, ICH Guidelines
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: GMP Quality Assurance, Root Cause Analysis, Quality Risk Management, Regulatory Inspection Readiness, People Leadership
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: Inventory Management, SAP, Forklift Operation, Data Entry, Shipping and Receiving
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: Upstream Manufacturing, CGMP Compliance, People Management, Cell Culture, Quality Management Systems
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: GMP Manufacturing, Bioprocess Unit Operations, Root Cause Analysis, CAPA, Change Control
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Enterprise Data Architect & Technical Lead (remote)
Montgomery County, Maryland, United States · Remote OK
$156k–$188k/yr
Senior+$287M raised
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: Data Architecture, Master Data Management, Middleware, Data Modeling, SQL
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: Project Management, Capital Project Management, Engineering, Vendor Management, Procurement
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Skills: Technology Transfer, Process Development, cGMP, Lean Manufacturing, Operational Excellence
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our c…
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Full-time
high school, bachelor degree
Competitive salaries, Flexible work arrangements, Extensive benefits package
Posted 12d ago
~40 hrs/week
Responsibilities
The role involves administering and maintaining controlled documents, records, and the document control system while supporting regulatory inspections. Responsibilities also include troubleshooting technical issues, conducting audits, and providing training on operational procedures.
Requirements
Candidates must have a minimum of a grade 12 education, with a bachelor's degree preferred. Applicants should possess 2-4 years of related experience, preferably within an FDA-regulated industry, and proficiency with electronic document management systems.
Full job description
Preparedness today, safer tomorrow.
Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.
Job Summary
The role is responsible for the administration and maintenance of the company’s controlled documents, records, and the document control system in accordance with company requirements. Monitoring completion of department tasks, training new employees and providing support during regulatory inspections.
Responsibilities
Document Control Support
Troubleshoot and provide support for internal customers with technical questions related to Document Control quality systems.
Support completion of department operational tasks related to record and document issuance, processing, reconciliation and archival.
Conduct routine audits of department operational processes and provide recommendations for improvement.
Conduct new department employee training on operational procedures and provide input on new and revised training content.
Quality System Support
Compile and report performance metrics for Document Control quality systems and provide recommendations to improve performance.
Administer and maintain the company’s Electronic Document Management System (management and maintenance of system information).
Creation of standardized procedures and work instructions for Document Control.
Creation and maintenance of training material for company’s Electronic Document Management System.
Represent the Document Control department on site and global projects.
Oversee assignment and tracking of internal customer requests, including responsibility for service requests from other departments in the organization.
Identify opportunities for improvement within scope of work.
Provide support during regulatory and internal inspections of Emergent quality systems.
Assists with the management of third party audits.
Other duties as assigned.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
Minimum of grade 12 education required. Bachelor degree preferred.
2-4 years related experience.
Experience in an FDA regulated industry.
Experience with electronic document management systems.
Strong computer skills with the Microsoft Office product line.
Basic understanding of regulations governing document control and records management.
The position requires excellent communication and organizational skills.
The position must have strong interpersonal skills and have good attention to detail.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.
We help prepare for today's challenges and tomorrow's threats.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
1998
Headquarters
Gaithersburg, Maryland
LinkedIn followers
49,780
Total funding
$287M
At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
Please note: It has come to our attention that there may be people posing as Emergent recruiters and hiring managers online, offering fraudulent opportunities to job seekers. Emergent will never ask for any financial commitment from a candidate as a pre-employment requirement. Learn more about recruitment fraud and how to protect yourself here: https://bit.ly/recruitment-fraud
Offices: 300 Professional Dr, Gaithersburg, Maryland 20879, US · 155 Innovation Dr, Winnipeg, MB R3T 5Y3, CA · 3500 N Martin Luther King Jr Blvd, Lansing, Michigan 48906, US · 50 Shawmut Rd, Canton, Massachusetts 02021, US · 401 Plymouth Rd, Plymouth Meeting, Pennsylvania 19462, US
ManufacturingPartneringM&ADevices DevelopmentVaccine DevelopmentTherapeutics Developmentand Contract Development and ManufacturingHealth CareBiotechnologyLife Science
We help prepare for today's challenges and tomorrow's threats.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
1998
Headquarters
Gaithersburg, Maryland
LinkedIn followers
49,780
Total funding
$287M
At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
Please note: It has come to our attention that there may be people posing as Emergent recruiters and hiring managers online, offering fraudulent opportunities to job seekers. Emergent will never ask for any financial commitment from a candidate as a pre-employment requirement. Learn more about recruitment fraud and how to protect yourself here: https://bit.ly/recruitment-fraud
Offices: 300 Professional Dr, Gaithersburg, Maryland 20879, US · 155 Innovation Dr, Winnipeg, MB R3T 5Y3, CA · 3500 N Martin Luther King Jr Blvd, Lansing, Michigan 48906, US · 50 Shawmut Rd, Canton, Massachusetts 02021, US · 401 Plymouth Rd, Plymouth Meeting, Pennsylvania 19462, US
ManufacturingPartneringM&ADevices DevelopmentVaccine DevelopmentTherapeutics Developmentand Contract Development and ManufacturingHealth CareBiotechnologyLife Science