Analyst I, Quality Control 6/4/2020
JOB DESCRIPTIONAPPLY 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.
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 routinely conducts monitoring, testing, SOP generation and revision, investigation, and implementation of new microbiological / analytical programs as needed.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.
* 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.
* Performs environmental monitoring during fill operations (as necessary)
* 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.
* Participate in investigations of OOS results and other related studies.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
* Uses analytical and statistical concepts to understand variable sin 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.
* Participate in and attend professional seminars, conferences and conventions.May require work on weekends and nights, travel, or work with 3rd party vendors.
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
* 3-5 years (MS with 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.
* 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
* The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
* The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
* Reasonable accommodations may be made to enable individuals with disabilities to perform the 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.
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.