Quality Assurance Group LeaderEurofins BPT-Columbia is looking for a Quality Assurance Group Leader to join our Quality Assurance team located in Columbia, Missouri. The QA Group Leader position is a mid-level professional position responsible for planning and managing the quality assurance group or program with the goal of improving quality processes and ensuring regulatory compliant development and testing services with Good Laboratory Practices (GLP) and/or Current Good Manufacturing Practices (CGMP) regulations. Works in GLP and/or CGMP areas of compliance.Responsibilities include management of day-to-day quality assurance activities within assigned team, mentoring and guiding staff, formulating and maintaining quality assurance goals and objectives, interpreting and communicating GLP and/or CGMP quality philosophy, performing quality reviews of controlled documents, working with Operations and Quality Management to develop quality metrics, serving as back up to Manager, Quality Assurance, developing and reviewing quality systems, mentoring and training quality assurance staff, scheduling and hosting client and regulatory audits, deciding whether to accept a product or continue business with a supplier or subcontractor, developing new approaches to solve problems identified during quality assurance activities, working with quality and operations management to develop and/or implement quality system improvement, performing internal and external quality audits, managing workflow and workload of quality assurance staff, keeping management team informed of significant issues or developments, designing and implementing quality training programs, investigating and responding to customer complaints regarding quality, driving investigations and CAPAs to completion, reviewing protocols, procedures, data, reports, and other documents to ensure accordance with specified regulatory requirements, working closely with study directors, principal investigators, and study owners to detect and resolve any quality issues, reviewing standard operating procedures for accuracy and consistency, updating Master Schedule in accordance with specified regulations and standard operating procedures, filing protocols, amendments, deviations, inspections, and other quality documents appropriately, and performing other related duties as required and directed.The ideal candidate would possess experience with GLP and/or GMP and knowledge of HPLC and/or GC, experience with LIMS system desirable, experience reviewing Empower, strong computer, scientific, and organizational skills, demonstrated leadership and vision in managing staff groups and major projects or initiatives, a demonstrated commitment to high professional ethical standards and a diverse workplace, excels at operating in a fast pace, community environment, excellent people manager, open to direction and a collaborative work style and commitment to get the job done, ability to challenge and debate issues of importance to the organization, ability to look at situations from several points of view, persuasive with details and facts, delegates responsibility effectively, and familiarity and/or experience in a laboratory setting is required.Qualifications include a Bachelor's degree and five (5) years of directly related (GLP and/or CGMP) experience is required, at least three (3) years of which includes GLP and/or CGMP Quality Assurance (not QC/R&D) work, a degree in a relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework is preferred, supervisory experience is required, familiarity and/or experience in a laboratory setting is required, and authorization to work in the United States indefinitely without restriction or sponsorship.Working schedule will be Full-Time, First Shift, M-F 8am-4:30pm.
Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply. No relocation assistance will be given. 25% travel may be required.
This position is NOT remote.What we Offer:Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Quality Assurance Group Leader in columbia at Unknown Company
This position is listed as contract and able to be worked remotely.