Specialist I, QA On the Floor


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.

The Specialist I for QA on the Floor is responsible for assuring the quality of products manufactured at the Emergent BioSolutions Baltimore Facility. The QA Specialist I will perform Quality on the Floor functions. Our QA Department provides expertise in problem-solving and process improvements.  The QA Specialist will interact with manufacturing personnel and Quality Engineers to provide guidance necessary to maintain and improve CGMP compliance at the company.


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

Key Duties will include:
•    Quality-at-the-source utilizing on the floor real-time batch record review, disposition, and in-process auditing.
•    Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained; includes documentation, follow-up and escalation of observations, and areas of concern.
•    Delivers QA oversight of manufacturing processes. 
•    Provides quality guidance to Manufacturing personnel to manage resolution of in-process deviations.
•    Writes and revises Standard Operating Procedures (SOPs). 
•    Reviews and approves CGMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations, and procedures. 
•    Makes recommendation to QA Management for the release of product based on QA record review and approval.
•    Actively involved in daily operations to meet schedules and resolve problems. 
•    Demonstrate strong organizational skills related to priorities and workload. 
•    Ability to solve problems independently and within a team environment.
•    Train and mentor Production personnel on manufacturing processes to resolve open issues resulting from record reviews, on the floor walkthroughs, and deviation issues.
•    Write, reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans.
•    Implementation of solutions for identified issues affecting daily manufacturing operations.
•    Represents QA to guide various project and technical meetings, as needed.
•    Support and manage existing and/or develop and implement new programs, processes designed to drive continuous improvement.
•    Review and approval of Standard Operating Procedures (SOPs), and Master Batch Records (MBRs) on eDocs.
•    Review of product master recipes and batch process orders in SAP.
•    Supports and assists Quality Systems on timely closure of CAPAs, Gap Analysis and Product Complaints.
•    Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits metrics on a monthly basis for Senior Management.
•    Participation in biomedical screening is required.

This will be a 1st shift (6:00 a.m. to 2:30 pm) Monday thru Friday position. Overtime and weekend work required as needed based on manufacturing needs.

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. 


BS or BA degree in Science or Engineering with 5-10 years of GMP experience.
•    Must have strong attention to detail.
•    Ability to manage multiple priorities and tasks in a dynamic environment.
•    Excellent written and verbal skills.
•    Ability to exercise judgment to determine appropriate corrective actions.
•    Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
•    Ability to use computer programs such as eDocs and SAP.
•    Ability to work in a team environment.
•    Proficient knowledge of CGMP. 
•    Coordinate multiple tasks simultaneously.
•    Understand and respond to a diverse population.
•    Gowning certification required.
•    Ability to make sound decisions regarding compliance-related issues with moderate supervision.
•    Strong leadership skills; high level of personal/departmental accountability and responsibility.
•    Minimum of one year in a FDA regulated industry.



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.


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.


  • 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