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I. JOB SUMMARY
The Supervisor, QC Microbiology position supports the Quality Control group at Emergent BioSolutions Camden Campus to maintain process optimization and manufacturing activities. The Microbiology Supervisor is responsible for maintaining a safe and professional work environment. They will supervise the following 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 may also conduct monitoring, testing, SOP generation and revision, investigation, and implementation of new microbiological programs as needed.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Supervise operational activities of laboratory personnel in an organized and efficient manner to prevent any delays in product release.
• Assist Microbiology Manager with all day-to-day production issues as they arise.
• Perform trend analysis for batch record turn around, deviations and OOS investigations.
• Implement quality improvement initiatives and corrective actions.
• Conduct microbiological qualitative and quantitative analyses of samples.
• Investigate, suggest, validate and implement new laboratory procedures/techniques.
• Provides expertise and troubleshoots microbiology related issues.
• Review record keeping and documentation of laboratory equipment maintenance.
• Review and update existing techniques, specifications, testing standards and SOPs or write new documents.
• Supervise and provide significant contribution to the development and implementation of CGMP.
• Document all procedures and results.
• Represent department in meetings with Production, QA/RA, Engineering and other related departments in the absence of the Microbiology Manager.
• Advise, recommend, and implement resolutions for quality issues and non-compliance.
• Maintain database of laboratory data tracking and trending.
• Ensure that all equipment is fully calibrated and validated.
• Work with the Microbiology Manager to author Microbiology related deviations, CAPA, OOS and OOL investigations.
• Assist Method Validation in validation report generation and review.
• Identify and recommend equipment, supplies and vendors for microbial analyses.
• Guide the professional development of supporting staff both as individual and as a group.
• Participate in interviewing process for hiring supporting staff.
• Participate and attend professional seminars, conferences and conventions.
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.
• Delegation-the individual delegates work assignments, gives authority to work independently, sets expectations and monitors delegated activities.
• Leadership-the individual inspires and motivates others to perform well and accepts feedback from others.
• 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.
• Management Skills-the individual includes staff in planning, decision-making, facilitating and process improvement; makes self-available to staff; provides regular performance feedback; and develops subordinates' skills and encourages growth.
• 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.
• 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.
Desired Minimum Qualifications
Education and Experience:
• B.S. in Microbiology/Biology or related field with a minimum of 5 years' experience in the Pharmaceutical or Biotechnology industry and 2 years' experience in a supervisory/leadership role. OR an M.S. with minimum of 3 years' experience including 1 year in supervisory/leadership role.
• Emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, quality control, validation and manufacturing processes is essential.
• Must have previous hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, Enhancement and Inhibition, LAL, Sterility, Bioburden Testing.
Necessary Knowledge, Skills and Abilities:
• Competent in the use of various computer programs of MS Access and Excel.
• Excellent communication, documentation and organizational skills.
• General knowledge of FDA regulations pertaining to cGMP's.
Note: The responsibilities and tasks outlined in this Job Description are not exhaustive and may require other duties as determined by the needs of the company.
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.
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.