A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.
Health, Dental, Vision, 401k and matching401k. Accelerated Analytical Laboratories is a full-service contract cGMP-testing laboratory. With a 19,000 sq. ft. laboratory
ISO 17025
accredited facility and a staff passionate about fast, reliable, and accurate results, we provide the testing services that industry-leading companies rely on.
ISO-17025
compliant and meeting cGMP regulations, we serve local, national, and international clients. Accelerated Analytical Laboratories is looking for a Quality Manger to lead our QA department, to suggest improvements, implement leadership, vision and manage the ISO and cGMP Quality Assurance Programs for the facility. This includes monitoring quality assurance specifications for materials and finished products and ensuring that these specifications are met, coordinating analytical validation of finished products, vetting analytical results, responding to customer inquiries, education of employees on the monitoring of product quality, GMP , OSHA safety and maintaining regulatory compliance while assisting operations with the development of new strategic goals and processes. Accelerated Analytical is a full-service Microbiology and Analytical Chemistry testing facility. We specialize in OTC, Cosmetic and Pharmaceutical testing under our cGMP and
ISO 17025
compliant testing program.
Responsibilities:
Ensure all records required by regulatory agencies for testing activities are generated and reviewed in accordance with 21CFR and ISO guidelines. Lead a team with up to five (5) direct reports. Ensure all tasks are completed in accordance with laboratory procedures and policies. Foster a cooperative work environment. Handle job responsibilities in accordance with Accelerated Analytical Laboratories ethic and appropriate professional standards and applicable state and federal law. Manage the QMS and implement continuous improvement. Act as liaison with external and regulatory parties on matters of Quality. Collaborate with department management and laboratory staff to maintain and improve quality standards. Create and implement changes to improve current processes and reduce costs. Maintain laboratory training system. Ensure the QMS facilitates rapid movement of samples and materials while maintaining traceability and control. Ensure rapid and timely review of testing and quality documents. Partner with laboratory leadership to vet, commission, qualify, and validate laboratory support equipment. Maintain and improve the laboratory equipment management system. Manage process optimization program that includes continual improvement programs for analyses, human capital development, and management systems Overall responsibility for environmental monitoring program. Overall responsibility for stability programs. Maintain QMS documentation and manage periodic document review. Obtain lab certifications, accreditation, and regulatory clearance, as required. Promote good customer relations with all AAL clients. Other duties as assigned.
Skills:
Attention to detail. Quality oriented. Good organizational skills. Good customer focus. Strong analytical and problem-solving skills. Collaborative team player. Ability to manage multiple tasks with competing priorities. Excellent analytical and problem-solving skills.
Qualifications:
Working knowledge of products and services. In-depth understanding of industry standards. Meticulous and diligent attributes. Great team player with the ability to work with minimal supervision. Experience using and maintain analytical equipment. Strong leadership and management skills. Proficient in computer technology and systems. Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation. Experience working in a cGMP regulated environment preferred. FDA and ISO Audit experience mandatory.
Education and Experience:
Bachelor's Degree in Chemistry, Microbiology or related Biology Science, with a minimum of eight (5) years lab experience. Five (5) years' experience in Industrial Chemistry or Microbiology with an emphasis in Pharmaceutical and/or Medical Device, OTC industry, or equivalent experience. Experience with the FDA, cGMP, ISO, and OSHA Minimum of one (1) year directing a functional team. Knowledge of LIMS and Trackwise Preferred.
Job Type:
Full-time Pay:
$75,000.00 - $100,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance
