Analyst III, QC Microbiology & Sterility
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 Quality Control Analyst III, Microbiologist position supports the Quality Control group at Emergent Biosolutions Canton, MA to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Clean Utility testing programs, microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. Implementation of new microbiological programs such as microbial identification, as well as environmental monitoring, utility testing, quality document generation and revision, and investigations.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Writes, revises, and reviews laboratory procedures
• Coordinates and processes departmental change controls
• Data review and trending to ensure integrity and adherence to SOPs and cGMPs
• Provide support for swab recovery studies and cleaning validation
• Laboratory sample receipt and tracking
• Packaging and sending samples to contract laboratories
• Compendial testing such as bioburden, endotoxin, TOC, conductivity, Gas Testing, Sterility testing, and growth promotion
• Equipment/instrument standardization and calibration, as required for testing per SOPs
• Supports daily collection of utility and environmental samples, including water and steam sample collection
• Completion of GMP worksheets
• Coordinates and performs laboratory investigations
• Data entry into laboratory data system
• Maintain inventory of laboratory supplies
• Daily laboratory upkeep and maintenance
• Supports validation activities such as facility and utility qualification and autoclave load patterns
• This position performs routine microbial analysis of product samples
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
• Bachelor’s Degree in Microbiology, Biological Sciences, or related fields experience
• 3-5 years of experience and knowledge in the pharmaceutical and/or biotechnology industry in sampling and testing of critical utilities and environmental monitoring within a GMP environment
• Strong technical writing skills
• Execution of complex microbiological methods such as gram-staining and microbial identification to species
• Extensive experience performing USP testing such as MLT, growth promotion, endotoxin, TOC, and conductivity
• Must be able to gown as required in Production and Quality Control Laboratory areas
• Strong aseptic technique experience
• Knowledge of cGMPs, safety, proper documentation, and data integrity
• LIMS (Laboratory Information Management System) experience is preferred, but not required
• Knowledge and application GMP principles and working in an EU/FDA regulated environment
• Strong communication skills; oral/written and listening
• Personal Competencies
• Interpersonal Skills
o Team building
o Consensus building
o Conflict resolution
• Critical analytical skills and strong verbal and communication skills
• Ability to work independently in conducting quality system and process audits
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio
• Excellent presentation skills, including written and verbal communication skills
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.
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.