Analyst III, Quality Control (33421_Rockville)
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 QC Analyst III, 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. T Individuals should be able to work independently and participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments. In this role, Individuals will use soft skills, to work on QC schedules and to work with internal customers (EHS, Manufacturing and QA). People leader skills will be cultivated in this role.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Assist the Manager, QC Micro / Analytical with feasibility assessment of client projects
• Perform microbiological / analytical work per method transfer/ validation programs.
• Perform environmental monitoring and utility testing of the facility.
• Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.
• Participate in investigations of OOS results and other related studies.
• Write, review, and revise SOP’s and Testing Standards as necessary.
• Train additional employees in methods transfers and techniques
• Review, analyze, interpret, and report data.
• Resource for technical knowledge of current assays
• Applies analytical knowledge to support change and risk management
• Review record keeping and documentation of laboratory equipment maintenance.
• Support department compliance and productivity goals.
• Track time worked per project.
• May require work on weekends and nights, travel, or work with 3rd party vendors.
• 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 general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education: BS in Microbiology/Biology or related field
Experience: 3-5 years (MS with 3+ years) in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes. . Track record of achievement and sustained performance in a cGMP/GLP environment. Strong technical and communication skills: oral/written and listening. Personal Competencies: Self – awareness, Integrity, Team Player, Creative and Flexible
Skills: Knowledge of MS Word, Excel and PowerPoint.
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.
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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.