Analyst III, Document Control

Location
Canton, MA
Posted
Jan 13, 2022
Ref
801802700
Required Education
Bachelors Degree
Position Type
Full time


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The QA Analyst III, Document Control is accountable for the execution of daily activities as related to documentation record management, archive, and retrieval of GMP controlled documents ensuring the site complies with relevant regulations and internal procedures. The role will contribute to organizational management on all electronic and paper-based systems that support daily activities of documentation management and proper design.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Document Control Support
•    Responsible for the documentation archival and record chain of custody and traceability for onsite and offsite documents for easy identification and retrieval
•    Perform routine verification to ensure latest documentation archived accordingly 
•    Execute daily activities that support documentation compliance and traceability to all executed activities
•    Achieve and maintain SME status on all functional area application systems and reporting tools such as Veeva Vault (Electronic Data Management System)
•    Troubleshoot and provide support for internal customers with technical questions related to Document Control quality systems.
•    Interact with external vendors to understand system functionality and solve computer system program issues.
•    Provide end user assistance/training for document control procedures
•    SOP generation and review, providing subject matter expertise to other document authors on site
•    Must be capable to work independently and strategically to ensure day¬to-day activities are carried out in support of the business goals

Quality System Support
•    Author and execute tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system performance.
•    Compile and report performance metrics for Document Control quality systems and provide recommendations to improve performance.

Site Support
•    Represent the Document Control department in a review and decision-making capacity on site projects.
•    Process access requests, perform user analysis, and make recommendations for relevant computer systems.
•    Develop, schedule, and conduct site training for supported quality systems.

Continuous Improvement
•    Coordinate and lead department 5S activities.
•    Identify opportunities for improvement within scope of work.

Regulatory Inspection
•    Lead logistical support and technical knowledge during regulatory and internal inspections of Emergent quality systems, including interacting directly with regulatory personnel to discuss areas of expertise.
•    Lead response teams to address observations and recommendations made during inspections.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
Minimum Requirements
•    BS degree or equivalent level of skill and experience.
•    5 years related experience.
•    Experience with electronic document management, non-conformance, CAPA, and change control systems.
•    Minimum of 3 years in an FDA regulated industry.
•    Minimum of 3 years records management experience.
•    High understanding of regulations governing document control and records management.
•    Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
•    Ability to work individually and in a team environment with minimal supervision.

Preferred Requirements
•    American Society for Quality (ASQ) Quality Process Analyst, Lean, or Manager of Quality/Organizational Excellence certifications.
•    Experience with Veeva Vault electronic document management system.
•    Microsoft Office Specialist certification.
•    Document Management Certified Professional (or equivalent certification).
•    Certified Records Manager (or equivalent certification).
•    Certified Information Professional (or equivalent certification).
•    CMII Professional (or equivalent certification).
 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

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.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

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 .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.