- Assist the Microbiology Supervisor/Manager with feasibility assessment of client projects
- Perform microbiological work per method transfer/ validation programs.
- Perform environmental monitoring and utility testing of the facility.
- Performs environmental monitoring during fill operations.
- Write method validation protocols and reports as necessary.
- Perform various microbiological 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.
- Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
- Write and review SOP's and Testing Standards as necessary.
- 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.
- 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.
- Participate in and attend professional seminars, conferences and conventions.
- 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.
- Quality Management-the individual looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
- Judgment-the individual displays willingness to make decisions, exhibits sound and accurate judgment, and makes timely decisions.
- Planning/Organizing-the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
- Building Strategic Working Relationships-develops and uses collaborative relationships to facilitate the accomplishment of work goals.
- 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.
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Analyst III, QC Microbiology, 3rd Shift- Wed-Sat - Baltimore, United States - BioSpace
Description
Job Details
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.
Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
The Analyst III, 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, SOP generation and revision, investigation, and implementation of new microbiological programs as needed.Shift:
Wednesday-Saturday 8pm-6:30am
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
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, SKILLSTo perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.
Education:
BS in Microbiology/Biology or related field
Experience: 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.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees.
This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.
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.
