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 Analyst II, QC Microbiology position supports the Quality Control group at Emergent BioSolutions Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, 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, and SOP generation and revision.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
* Perform various microbiological testing procedures as per Manufacturing/Quality Control batch records, stability protocols, raw material requests for testing, etc.
* Perform environmental monitoring and utility testing of the facility.
* Performs environmental monitoring during fill operations.
* Work with Project Managers and QA to ensure timely testing and release of samples.
* Inform supervisor/manager upon observing OOS, OOL, or generation of deviations
* Participate in investigations of OOS results and other related studies.
* Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues.
* Investigate and suggest new laboratory procedures/techniques.
* Validate and implement new laboratory procedures/techniques.
* Update existing or write new testing standards and standard operating procedures.
* Train Microbiologist I & II in methods and techniques
* Review, analyze, interpret and report data.
* Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
* Support department compliance and productivity goals.
* Write and review monthly reports as necessary
* Track time worked per project.
* Participate in and attend professional seminars, conferences and conventions.
* Participation in biomedical screening is required.
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
To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.
* Technical/Professional Knowledge- having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.
* Problem Solving- the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.
* Safety and Security-the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.
* Communication- the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
* Quality Management- the individual looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
* Planning/Organizing- the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
* Adaptability - maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
* Stress Tolerance- maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization.
Education: BS in Microbiology/Biology or related field
Experience: Minimum 2-4 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology with emphasis in one of the following areas: aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.
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.