Description:Microbial Investigations: 1st shift typical hours but will need flexibility to come in on off shifts as part of investigations. This is where your creativity addresses challenges. The MO Microbial Out-of-Limits Investigator leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation determining root cause and defining effective corrective and/or preventive actions to prevent recurrence. The Investigator partners with Quality Operations Engineering Maintenance and Supply Chain to ensure appropriate and timely determination of scope product impact root cause and CAPAs. Interacts with all levels of staff and provides timely updates on investigation status. Manages several investigations at a time. Your Team Within Quality every role makes a difference. Products that makes them unique are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product it is sure to touch a portion of our global operation. The mission of this company is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds we will always choose quality. Our patients come first always. What you'll be doing:-Determines scope product impact root cause corrective and/or preventive actionsof microbial excursions including surfaces viable air non-viable air waterbioburden and endotoxin testing results -Expeditiously identifies potential root causes for excursions and immediatemitigation actions -Assembles cross-functional teams conducts interviews observes operations tocomplete investigations and lead process improvement CAPA projects to timelyand effective closure -Fosters collaborative relationships focused on high-quality and timelyinvestigations effective corrective actions and the reduction of out-of-limitgeneration rate -Closes investigations in a timely manner to meet business and compliance needs -Works with minimal supervision to drive investigations to closure -Works with Subject Matter Experts and Quality Approvers to determine scopeidentify root causes and implement corrective/preventive actions -Manages investigation and CAPA documentation in TrackWise in compliance with practices and procedures -Understands and implements procedures that support implementation of CAPAs -Presents and defends investigations during regulatory inspections as required What you'll bring: -Bachelor or Masters degree in science in Microbiology or related field with 2years of experience in conducting root cause investigations in thepharmaceutical/medical products industry -Minimum of 5 years of experience in Quality Operations Microbiology Laboratoryand/or Quality -Strong communication and project management skills -Must have thorough understanding of pharmaceutical/medical device manufacturingand current Good Manufacturing Practices and Good Documentation Practices -Must have good analysis troubleshooting and investigation skills includingknowledge and understanding of problem-solving methodologies e.g. DMAIC -Must have strong technical writing skills and able to put complex thoughts andissues into writing in such a manner that can be understood by the reader -Must be able to interact with and influence others at various levels inmultiple departments -Must have knowledge of FDA quality systems regulations -Must have working knowledge of TrackWise systemAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
