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Analyst III, Quality Assurance (Systems), Document Control

Location: 

Baltimore (Camden), MD, US, 21230


 

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.

I.    JOB SUMMARY 
The role of the Analyst III, Document Control Quality Assurance requires advanced knowledge and understanding of electronic document management systems (EDMS).  This individual must be knowledgeable with GDP and CGMPs regulations.  This position serves as a subject matter expert (SME) for the site in regards to EDMS.

 

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

Key responsibilities associated with this role include but are not limited to the following:
•    Excellent working knowledge of the EDMS program.
•    Work with corporate and other sites to harmonize procedures and processes as required.
•    Provide technical mentoring and coaching to site staff regarding EDMS.
•    Act as a trainer on EDMS and other GDP functions (i.e., serialization, Veeva level II).
•    Respond to internal and external audit findings.
•    Prepare and present reports and metrics to leadership around documents (DCCs, biennial reviews)
•    Additional Quality Assurance activities as required.
•    Support the Training Department as needed.
•    Revise Quality Assurance SOPs as required to ensure procedures are compliant with CGMP.

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. 

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Degree in a scientific discipline with a minimum of 8+ years of related experience. required.
•    Expert knowledge of industry principles and concepts.
•    Demonstrated success in independent judgment, technical proficiency, collaboration with others in a cGMP environment.
•    Computer skills (EDMS, MS Office)
•    Strong technical and communication skills: oral/written and listening.
•    Behavioral Competencies: Initiative, Personal Leadership, Interpersonal Effectiveness, Productivity, Decision Making.
•    Work with multiple functional/departmental personnel at various levels in the facility. Ability to work with multi-departmental team.
•    Ability to present summaries of discussions and process flows (oral and written).
•    Aseptic manufacturing and/or Contract Manufacturing Organization experience preferred.

 

IV.     PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
 

 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore