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 Quality Control Analyst III, Microbiologist position supports the Quality Control group at EMOB to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the EMOB 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, mycology, and metal analysis, 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 MLT, growth promotion, endotoxin, TOC, and conductivity
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
Daily collection of utility and environmental samples, when necessary
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.
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 managements assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelors Degree in Microbiology, Biological Sciences, or related fields experience
Minimum 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
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.ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support each other.
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves to constantly improve.
- Own it always
- Every person at Emergent is engaged and accountable for delivering on our commitments.
- Compete where it counts
- We set the right goals and respect each other as we conquer them together.