Analyst II, QA Raw Materials

Location
Baltimore (Camden), MD, US
Posted
Sep 28, 2020
Ref
657109700
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

The QA Analyst II is responsible for performing duties related to raw materials review and release for the CGMP operation of Emergent BioSolutions Emergent BioSolutions at the Baltimore Camden Site. Our QA Department provides expertise in problem solving and process improvements. The QA Analyst will interact with all departments to provide guidance necessary to maintain and improve CGMP compliance at the company.

ESSENTIAL FUNCTIONS

Raw Materials:
  • Perform critical reviews of Incoming material documentation submitted for QA disposition.
  • Perform activities associated with the Active Pharmaceutical Ingredient (e.g. receipt, inspection and document review).
  • Perform AQL Inspection of Printed Materials.
  • Create, edit and review Incoming Material Specifications.
  • Contributes to writing Standard Operating Procedures and revisions as it pertains to Raw Material Disposition and Incoming Material Specifications.
  • Respond to various interdepartmental requests. Answer questions and provides feedback to ensure Quality and departmental objectives are met.
  • Scanning and ancillary filling.
  • Keep management informed of concerns/issues/successes.
  • Within area of responsibility, understand and comply with all safety and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs.
  • Perform other duties assigned to enable organizational and quality objectives to be met

Continuous Improvement:
  • Identify opportunities for improvement within scope of work.
  • Participate in Lean Six Sigma activities.


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 degree in Chemistry/Biology or related discipline with 1-3 years Quality Control or Quality Assurance experience or a MS degree in Chemistry/Biology or related discipline with at least 1-year Quality Assurance experience, preferred.
  • 1 year in an FDA regulated industry is preferred.
  • 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.
  • Ability to work in a team environment.
  • Working knowledge of cGMP.
  • Ability to make sound decisions regarding compliance-related issues with moderate supervision.


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.