Specialist I, QA on the Floor

Location: 

Baltimore, 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 Quality Assurance Specialist I On the Floor will perform Quality on the floor functions at the Emergent BioSolutions Baltimore Camden Facility. Quality Assurance Specialist I On the Floor primary responsibility is to provide Quality Assurance oversight and support real-time for all areas that are directly or indirectly involved in the execution of GMP-related activities. Quality Assurance Specialist I On the Floor make decisions regarding both simple and complex events that occur in the GMP environment. Quality Assurance On the Floor Specialist I demonstrate an understanding Quality Systems, Manufacturing practices, Good Documentation Practices, as well as professional skills of effective communication and listening. Adherence to cGMPs is required at all times during the manufacture of sterile products.  All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.Develops leadership skills such as coaching and feedback. Additional process improvement projects may be assigned for independent work. Provides training and mentoring for less experienced staff.

 

The Role also includes Quality Assurance oversight of Facilities and Engineering work in the GMP areas and areas that impact GMP production. QA Department provides expertise in problem solving and process improvements.  The Quality Assurance Specialist I On the Floor will interact with manufacturing personnel and the Quality Engineer to provide guidance necessary to maintain and improve CGMP compliance at the company.

 

II: ESSENTIAL FUNCTIONS

Key Duties will include:
•    Quality Unit oversite 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 the documentation, follow up and escalation of observations and areas of concern.
•    Quality Unit oversight of manufacturing processes and aseptic techniques. Upon observation of a grievance activity that could impact product quality and safety, request stoppage of production activity, escalates to Production, Quality Control and Quality Management, provides quality guidance to manufacturing personnel to manage resolution of in-process deviations.
•    Participate in daily tier meetings with site partners.
•    Partner with Operations and Production to meet schedule requirements and resolve challenges.
•    Write and revise Standard Operating Procedures (SOPs). 
•    Review and approval of GMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations and procedures. 
•    Makes recommendation to Quality Assurance Management for the release of product based on in process Quality Assurance record review.
•    Actively involved in daily operations to meet schedules and to resolve problems. 
•    Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and in a team environment.
•    Write, reviews, and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans.
•    Represents Quality Assurance 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).
•    Review of product master recipes and batch process orders in SAP.
•    Supports and Assists Quality Systems on timely closure of CAPA’s, Gap Analysis and Product Complaints.
•    Track and trend metrics for Quality Assurance On the Floor audits, Logbook audits and In-Process Audits metrics monthly for Senior Quality Assurance Management.
•    Delivered a structured approach to oversight the aseptic operations for all filling lines including cleaning processes. 
•    Be present in the prep, formulation, fill rooms to perform real time feedback, correction, and review of aseptic operations
•    Document and report the oversight results as required by current standard operating procedures and corresponding GMP forms.
•    Coach and mentor personnel working in the aseptic core including but not limited to Operations, Microbiology and Engineering personnel to foster a climate of routine inspection readiness.


III: MINIMUM EDUCATION, EXPERIENCE, SKILLS
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 an FDA regulated industry.

 

IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
 

 

 

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 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