Manager, cGMP Quality Assurance
5 - 7 years experience • Professional, Scientific & Technical Services
Our compay has an opening for a Manager, Quality Assurance at the Columbia, Missouri laboratory. EAG Laboratories / Eurofins BioPharma Testing has delivered expert scientific support to companies working to improve human and animal health. As a member of the team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment. Our laboratories are modern. Our instrumentation is state of the art. And our business is thriving, creating important career opportunities.
The Manager, Quality Assurance serves as manager for quality assurance systems with 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.
Job Duties and Responsibilities:
- Responsible for management of day-to-day quality assurance activities within quality assurance group. Serves to mentor, guide, advise, and otherwise support staff in their work. Includes appropriate training and instruction.
- Delegates work to various teams and/or individual employees as appropriate. May create or reorganize teams as necessary.
- Review staff work as necessary prior to submittal and sign-off.
- Formulates and maintains quality assurance goals and objectives complementary to corporate policies and goals.
- Interprets and communicates GLP and/or CGMP quality philosophy to appropriate personnel within the organization.
- Performs quality reviews of controlled documents to ensure GLP and/or CGMP systems are implemented consistently.
- Works with Operations and Quality Management to develop, implement, maintain and interpret Quality metrics to improve Quality Systems.
- Serves as back-up to Sr. Director, Quality Assurance in times of absence as needed.
- Develops, implements, and reviews all quality systems.
- Mentors and trains GLP and/or CGMP quality assurance staff to develop a cross-trained staff of quality professionals. Provides guidance and mentoring in the areas of conflict resolution.
- Schedules, coordinates, and hosts client and regulatory GLP and/or CGMP audits and responds to any audit observations.
- Decides whether to accept a product or continue business with a supplier or subcontractor based on GLP and/or CGMP quality audit or review.
- Develops new approaches to solve problems identified during quality assurance activities.
- Works with quality and operations management to develop and/or implement quality system improvement.
- Performs internal and external quality audits.
- Manages workflow and workload of GLP and/or CGMP quality assurance staff, through prioritization and planning to assure that project, facility, and vendor materials are QA reviewed and/or approved in a timely manner.
- Keeps quality assurance leadership informed of significant issues or developments identified during quality assurance activities and corrective action/preventive actions (CAPA) being taken to improve the situation.
- Designs and implements quality training programs within QA and company-wide, as appropriate.
- Investigates and responds to customer complaints regarding quality.
- Drives investigations and CAPAs to completion.
- Reviews protocols, procedures, data, reports, and other documents to ensure accordance with specified regulatory requirements, protocol, and/or project plan, methods and SOPs.
- Works closely with study directors, principal investigators, and study owners to detect and resolve any quality issues.
- Reviews standard operating procedures for accuracy and consistency to ensure agreement with regulations.
- Updates Master Schedule in accordance with specified regulations and standard operating procedures.
- Files protocols, amendments, deviations, inspections, and other quality documents appropriately.
- Performs other related duties as required and directed.
- Bachelor's degree and eight years of directly related (GLP and/or CGMP) experience is required, at least three years of which includes GLP and/or CGMP Qaulity Assurance.
- Supervisory experince is required.
- A degree in a relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other direclty related field or degree with comparable coursework preferred.
- Familiarity and/or experience in a laboratory setting is preferred.
In addition to minimum requirements listed above, will assess against preferredqualifications:
- Experience in GMP pharmaceutical analytical lab.
- Experience with Pharmaceutical Quality Systems.
- Experience with Quality Metrics and utilizing them to manage groups and/or businesses.