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Quality Control Analyst II

Company: Emergent Biosolutions
Location: Rockville
Posted on: September 22, 2022

Job Description:

Emergent BioSolutions is a global life sciences company dedicated to one simple mission to protect and enhance life. We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. Through our work, we envision protecting and enhancing 1 billion lives by 2030.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 QC Analyst II, position supports the Quality Control group at Emergent BioSolutions Rockville Campus. The role requires knowledge and understanding of scientific concepts, practices and procedures within the biopharmaceutical field and a cGMP environment. The role is responsible for daily routine testing and laboratory maintenance tasks such as Environmental Monitoring of the GMP area, and sampling and testing of water, compressed air, nitrogen and bioburden testing samples. Individuals should be able to work independently and participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.--- Basic understanding of compliance/guidance/regulation pertaining to assigned are.--- Perform routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.--- Perform environmental monitoring during fill operations.--- Perform daily checks on equipment.--- Stock the lab on a regular basis.--- Inform Manager upon observing OOS, OOT, or deviations.--- Participate in investigations of OOS results and other related studies.--- Verifies and enter results in LIMS.--- Practice Good Documentation per the Standard Operating Procedures.--- Review record keeping and documentation of laboratory equipment maintenance.--- Support department compliance and productivity goals.--- Track time worked per project.--- Detailed oriented - Able to complete required tasks and associated documentation with minimal error.--- Adaptability - Maintain positive attitude in a changing work environment.--- Communication - Effectively communicates with all levels of manufacturing and support staff.--- Escalates issues through the proper channels. Requires vaccination against different viruses including Vaccinia virus. 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 Education: BS in Microbiology/Biology or related fieldExperience: 2-4 years in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.Skills: Knowledge of MS Word, Excel and PowerPoint.Job Type: Full-timeBenefits: 401(k) 401(k) matching Dental insurance Flexible schedule Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan Tuition reimbursement Vision insuranceSchedule: 10 hour shiftSupplemental pay types: Bonus payCOVID-19 considerations:Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment.Education: Bachelor's (Preferred)Experience: GxP: 2 years (Preferred) cGMP: 2 years (Preferred) SOP: 2 years (Preferred) Aseptic technique: 2 years (Preferred) Microbiology: 2 years (Preferred) Biotechnology: 2 years (Preferred) FDA regulations: 2 years (Preferred)Work Location: One location

Keywords: Emergent Biosolutions, Rockville , Quality Control Analyst II, Professions , Rockville, Maryland

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