Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. Eurofins PSS gives our clients an insourcing solution for all of their analytical testing needs. Are you looking for the opportunity to use your skills in order to impact a team in a fast paced environment towards our ultimate goal of testing for a better life? We can provide you meaningful work in a highly supportive and collaborative environment where we invest in you because our people are our chemistry!
Job Description
Our PSS team is looking for a qualified manufacturing investigator group leader to support a client directly onsite in northeastern North Carolina just outside of the RTP area. This position will manage the manufacturing investigation process to ensure on time closure of Quality Assurance Reports (QARs) including leading and facilitating Method 1 analysis, identifying true root cause, ensuring effective CAPA's are implemented and authoring reports which adhere to the QMS Writing Guide template.
Responsibilities:
Ensure robustness of investigations through application of the DMAIC methodology.
Perform walkthroughs of areas where deviation occurred and ensure thorough understanding of associated manufacturing processes.
Collect and evaluate documentation required to support investigation (i.e. logbooks, batch records, test results, etc.)
Organize and lead cross functional team meetings including initial and follow up Method 1 meetings.
Drive the identification and implementation of effective CAPAs to support reduction in deviations.
Coordinate review of investigation with Team Lead, Area Manager, Site Quality Authority, Subject Matter Experts, etc., address review comments, obtain alignment and ensure approval and closure of the investigation.
Manage workload and ensure adherence to a 30-day investigation closure process, including escalation of roadblocks which could result in delays.
Provide overview of investigations during regulatory inspections, internal audits and customer audits and respond to verbal and written inquiries.
Participate in and support IMEX processes (Visual Management, Standard Work, CI)
Qualifications
BS in an engineering or scientific discipline.Exceptions may be considered where relevant skills/experience exist.
Minimum of 1 year of manufacturing investigation experience within a pharmaceutical, regulatory and/or biotechnology industry.
Previous experience with use of standard investigative tools (fishbone, Ishikawa, is/is-not, etc.)
Familiarity with SMART CAPA and CAPA Effectiveness evaluation
Strong oral, written communication, presentation, interpersonal and project management skills.
Capable of interfacing with multiple levels of people within the organization including senior leadership, third party customers and site personnel.
Technical writing and problem-solving skills required.
Demonstrated ability to act decisively and independently to resolve issues.
Additional Information
Position isfull-time, Monday-FridayCandidates currently living within a commutable distance ofRocky Mount , NCare encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
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Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
