Specialist I, Quality Control

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 Specialist I, 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 QC Specialist I is responsible for performing activities in support of the Microbiology, Environmental Monitoring, Analytical (including testing and method transfer) and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual will also assist in coordinating the preparation and conduct of study protocols, data analysis, reports and standard operating procedures (SOPs) that support manufacturing activities and complex investigations to identify root causes and CAPAs to avoid reoccurrence. An individual in this role will serve as an SME for QC on cross functional Teams.

ESSENTIAL FUNCTIONS

• Assist the QC Manager, with feasibility assessment of client projects
• Perform microbiological / analytical work per method transfer/ validation programs.
• Perform environmental monitoring and utility testing of the facility.
• Write method validation / transfer protocols and reports as necessary.
• Perform various microbiological / analytical testing procedures per Quality Control batch records and stability protocols.
• Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.
• Assist with complex investigations by obtaining root cause and implementing changes.
• Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
• 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.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Resource for technical knowledge of current assays
• Assess the compliance status of current test methods and equipment
• Applies analytical knowledge to support change and risk management
• Review record keeping and documentation of laboratory equipment maintenance.
• Work with Project Managers and QA to ensure timely review and approval of protocols /reports.
• Support department compliance and productivity goals.
• Participate in meetings as required.
• Track time worked per project.
• Interview and recommend the employment of technical and professional supporting staff.
• Identify and implement continuous improvement opportunities to reduce non-value-added work or complexity.
• 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.
• Actively participate in department level meetings.
• Escalates issues through the proper channels.

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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BS in Microbiology/Biology or related field
• 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.
• Self - awareness, Integrity, Team Player, Creative and Flexible
• Knowledge of MS Word, Excel and PowerPoint.

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.