Analyst I, QA, Document Control - Baltimore, United States - Emergent Biosolutions

Emergent Biosolutions
Emergent Biosolutions
Verified Company
Baltimore, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
We are dedicated to tackling major public health challenges, safeguarding and improving millions of lives, and striving to build a safer world.

At our company, you will be part of a team of passionate experts who continuously enhance their scientific, technical, and professional abilities to create life-enhancing products.

I. JOB SUMMARY
Support document and records management in Document Control according to company protocols and guidelines to assist GxP operations, which involve issuing, reconciling, processing, scanning, and archiving records. Conduct system and process training, monitor department task completion, train new staff, and provide assistance during regulatory inspections.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be provided for individuals with disabilities to carry out essential functions:
  • Support department operational tasks related to document and record lifecycle stages, including issuing, reconciling, processing, scanning, and archiving records
  • Ensure timely availability of documents to support manufacturing schedules
  • Assist during regulatory and internal inspections of quality systems
  • Participate in developing and maintaining an electronic document management system
  • Manage records archives onsite and offsite
  • Assist internal customers in resolving technical Document Control issues
  • Expand knowledge of electronic document management systems
  • Perform other assigned responsibilities

The job duties outlined above are representative, and not exhaustive of all tasks performed.
This job description does not limit management's ability to assign or reassign duties and responsibilities as needed.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • High school diploma or equivalent
  • Minimum of 3 years of document-related work experience
  • Experience in GmP, FDA-regulated industries, and/or electronic document management systems is advantageous
  • Proficient in Microsoft Office suite
  • Exceptional attention to detail
  • Effective communication skills (oral and written) with internal stakeholders at all levels
  • Ability to work independently and collaboratively with minimal supervision
  • Manage multiple tasks simultaneously and prioritize to meet deadlines

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Following CDC guidelines, it is strongly recommended that all on-site employees at Emergent receive vaccination for their safety and that of their colleagues. Use good judgment per CDC advisement when considering staying home if feeling unwell. Reasonable accommodations will be provided for individuals with disabilities to perform essential functions.
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