Analyst I, Document Control

Location
Canton, MA
Posted
Jan 24, 2022
Ref
825793100
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 Analyst I, Document Control is accountable for the execution of daily activities as related to documentation record management, archive and retrieval of GMP documents, controlled documents and ensure the site complies with documentation CFRs. The role will contribute to organizational management on all electronic and paper-based systems that support daily activities of documentation management.

 

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

Document Control Support
•    Execute daily activities that support documentation compliance and traceability to all executed activities
•    Ensure maintenance of documentation archival and record chain of custody and traceability for onsite and offsite documents
•    Achieve and maintain SME status on all functional area application systems and reporting tools such as Veeva Vault (Electronic Data Management System)
•    Collaborate with team members and site customers to ensure timely deliverables for documentation and training objectives
•    Provide end user assistance/training for document control procedures
•    SOP generation and review
•    Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
•    Frequently interacts with direct manager, peers, internal customers, and other cross functional peers across Emergent.
•    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.
•    Support completion of department operational tasks related to record and document issuance, processing, and archival.
•    Ensure maintenance of documentation archival and record chain of custody and traceability for onsite and offsite documents for easy identification and retrieval
•    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)
•    Collaborate with team members and site customers to ensure timely deliverables for documentation and training objectives
•    Provide end user assistance/training for document control procedures

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
•    Bachelor’s Degree in Scientific or related fields
•    A minimum of two (2) years of cGMP in QA documentation in Pharmaceutical industry 
•    Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
•    The ability to coordinate multiple priorities in a fast-paced environment
•    Excellent organizational, analytical and problem-solving skills 
•    Excellent communication skills with the ability to interact with all levels throughout the organization
•    Must be a team player and work collaboratively in a complex matrix environment 

Preferred Requirements
•    Microsoft Office Specialist certification.
•    Document Management Certified Professional (or equivalent certification).
•    Certified Records Manager (or equivalent certification). 
•    Experience in maintaining CGMP compliance preferred.

 

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.