Supervisor, QC Microbiology

Company: Packaging Coordinators, Inc.
Location: Madison
Posted on: January 27, 2023

Job Description:

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.JOB SUMMARY Responsible for the day-to-day operations of the QC Microbiology laboratory which include overseeing the environmental monitoring of classified spaces and the routine testing of the USP controlled utility systems and applicable microbiological assays of in-process samples and finished product. Ensure the timely testing and release of all samples. Relies on previous experience, analytical skill, and knowledge to make judgments to accomplish goals.JOB DUTIES

• Supervise lab personnel and provide oversight for personnel work schedules.
• Mentor and develop staff to meet technical and business needs.
• Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring and water/clean steam data for LSNE facility sites and writes quarterly reports summarizing these data.
• Perform and document investigations into Environmental Monitoring excursions and incidents which occur during aseptic filling and routine monitoring.
• Perform risk assessments and investigations with effective CAPAs.
• Work with and provide input to Operations and Facilities groups to maintain the sterility or aseptic nature of processes.
• Performs initial identification of microbial contaminants and/or isolates.
• Oversee and perform as necessary endotoxin, bioburden, growth promotion of media, environmental monitoring, and critical utilities collection and testing.
• Coordinate and support validation, calibration, and maintenance of microbiology laboratory equipment and instrumentation.
• Maintain positive relationship and network effectively across sites, organizations and clients.
• Ensure cGMP compliance of all activities performed and on time delivery of quality results.
• Write and review standard operating procedures and coordinate method development and validation of microbiological methods.
• Work and guide personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with regulatory guidance.PROFESSIONAL SKILLS
  • Excellent organizational skills
  • Strong oral and written communication skills
  • Proficient in statistical and data analysis
  • Ability to multi-task
  • In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programsEXPERIENCE
    • Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology
    • Previous experience in aseptic manufacturing highly preferredEDUCATION
      • Master's Degree in Microbiology, biology or similar life science preferred with at least 3-5 years experience in Pharma or Biotechnology Quality Control cGMP
      • Alternatively, a BS Degree in Microbiology, biology or similar life science with greater than 5 years of intensive experience may be consideredQUALITIES
        • Self-motivated with a drive for excellence; able to inspire and motivate staff
        • Positive attitude and strong interpersonal skills
        • Honesty, integrity, respect and courtesy with all colleagues
        • Able to work in a highly complex environment with competing demands and priorities
        • Able to deal with ambiguityPHYSICAL REQUIREMENTS & MENTAL DEMANDS
          • Must be able to work at all LSNE sites inclusive of remote locations
          • Ability to gown and work in an ISO environment
          • Able to lift to 20 lbs.
          • May occasionally support off shift activities.COMMUNICATIONS & CONTACTS
            • Works closely with Quality Assurance, Operations, and Facilities staff in performing varied work procedures and activitiesMANAGERIAL & SUPERVISORY RESPONSIBILITIES -
              • Manages and develops subordinate staff
              • Assigns responsibilities and duties within the group
              • Provides constructive feedback to team and authors performance reviews within corporate timelinesTRAVEL
                • #LI-LL1Join us and be part of building the bridge between life changing therapies and patients. Lets talk future (https://pci.com/) Equal Employment Opportunity (EEO) Statement:PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Why work for PCI Pharma Services?At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we dont say no, we figure out how.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Keywords: Packaging Coordinators, Inc., Madison , Supervisor, QC Microbiology, Other , Madison, Wisconsin