Analyst II, Quality Assurance

Location
Rockville, MD, US
Posted
Oct 25, 2020
Ref
647510000
Hotbed
BioCapital
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.

JOB SUMMARY

QA Analyst II is responsible for assuring the quality of products filled, inspected, labeled, and packaged at the Emergent BioSolutions Rockville facility. QA Analyst II will perform quality functions on the production floor to support manufacturing activities. Our QA Department provides expertise in problem solving and process improvements. The QA Analyst II will interact with all departments to provide guidance necessary to maintain and improve cGMP compliance at the site.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Batch Review and Production Support
  • QA on the floor for Manufacturing and QC, providing quality oversight of production and QC inspection/testing processes.
  • Critically reviews executed GMP documents such as batch records, logbooks, EM data, and cycle reports.
  • Write / revise Standard Operating Procedures (SOPs) in the document management system.
  • Review and approve GMP documents such as SOPs, master production batch records, forms, and logbooks in the document management system.
  • Actively involved in daily operations to meet schedules or to resolve problems.
  • Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
  • Quality Systems Support
  • Author and execute tasks for document revisions, deviations, CAPAs, and change controls related to the QA team.
  • Review and approve work orders, preventive maintenance, and calibration records as needed.
  • Perform trend evaluation and reporting of data for Quality Management Review.
  • Review of deviation investigations, root cause analysis, and CAPA identification.
  • Continuous Improvement
  • Identify opportunities for improvement within scope of work.
  • Support Operational Excellence initiatives related to the QA team.
  • Inspections/Audits
  • Participate in inspections/audits by providing documentation to fulfill requests for information and contributing in the inspection/audit as needed.

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
  • BS or BA degree preferred with 3 years of GMP experience in QA/QC role
  • Minimum of one year in a FDA regulated industry.
  • 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 Veeva and SAP.
  • Ability to work in a team environment.
  • Proficient knowledge of cGMP.
  • Coordinate multiple tasks simultaneously.
  • Understand and respond to a diverse population.
  • Ability to make sound decisions regarding compliance-related issues with moderate supervision.
  • Strong leadership skills; high level of personal/departmental accountability and responsibility.
  • Requires vaccination against various viral products, including the Vaccinia virus.


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.