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Quality Analyst III, Microbiology
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
As a Quality Analyst III, you will support the daily operations of the Microbiology Lab and other functional groups. You will need to manage and track the completion of the testing documentation, data entry, data review and trending for Microbiology data in a timely manner.
- Perform a wide variety of microbiological testing methods, but not limited to raw material testing, raw material qualification and water testing
- Perform, analyze, and review water sampling/testing, sterilization of equipment, growth promotion, endotoxin, microbial identification, biological indicator, and bioburden testing data
- Demonstrate software usage, data analysis and interpretation of testing data and trends
- Ensure that required electronic data and documentation (raw data, testing records, and logbooks) are completed, reviewed, and trended accurately and entered in timely manner
- Drive the testing data entries, tracking, and trending to completion
- Initiate, investigate, resolve and complete event records within our controlled event system TRACKWISE
- Assist Failure Investigation Team in gathering data for major/complex events
- Review trending Microbial Identification data and its completion
- Distinguish various microorganisms and know when escalate to management when issues arise
- Operate and maintain lab equipment as required by SOPs and testing procedures
- Support SOP revision processes, Item Specification, and other related documentation
- Lead protocol and special study executions.
- Execute protocol and final report writing for special studies and projects.
- Participate in scheduling team's weekly schedule and managing group meeting in the absence of Microbiology Management
- SME for the junior analysts in routine and non-routine tasks
- Distinguish potential issues and professionally suggest potential solutions based on quality system guidelines and regulatory guidance
- Assess current test method, current practice, and suggest process improvements to ensure regulatory guidance area followed and compliance area met
- Prioritize tasks to ensure that projects are completed by the assigned deadlines.
- Support team building by participating in interviewing new talent.
- Comply with company EH&S requirements. Promote a safety-first culture.
- The work environment is fast-paced and demanding.
- This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions.
- Upon managers request may
have toadjust work schedule and work weekends
- May occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials.
Sit and reach to use computers and other office/lab equipment
- Stand for extended periods of time, up to four (4) to five (5) hours/time
- Lift up to fifty (50) pounds
- View objects at close and distant ranges
Who you are:
- Bachelor Degree in Biology, Microbiology, Chemistry or other life science discipline with 3+ years of quality analysis experience OR a High School Diploma or GED with 4+ years of quality analysis experience
- 1+ years of experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, and electronic software.
- 1+ years of cGMP, aseptic techniques, and microbiology testing
- 1+ years of experience with electronic software TRACKWISE, LIMS or Novatek
- Previous knowledge/experience with automation, troubleshooting for machineries, equipment, and data integrity
- Understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceutical
- Previous knowledge/experience with Aseptic Gowning
- Trained in performing Bioburden and Endotoxin Qualification
- Complete work independently and efficiently based on current SOPs and study protocol with minimal supervision
- Work independently and efficiently based on current SOPs, study protocol, regulatory guidance and industry practice with no supervision.
- Flexible and a team player
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.