General schedule will be Monday - Friday from 4:00AM to 12:30PM

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Pay Range: $92K - $98.5K

Sr. Quality Assurance Specialist

Are you looking for a challenging and rewarding opportunity in a fast-paced environment?Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business?Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?

Job Description

Support the planning and coordination of all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes at the site or multi site level.Responsible for requests for quality support from the site and communicates policies and procedures. The subject matter expert regarding selected governmental regulations for the site(s).Act as the primary quality assurance customer contact for the site.

Supervise the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.Coordinate select licenses, permits, and registrations.Analyze information and product specifications to determine regulatory compliance with regards to products handled and services performed at the site.Lead select key regulatory, customer and 3rd party audits.Monitor the training and development of site associates to ensure compliance to processes and regulationsManage Quality Technicians within the site, as applicable. Track and maintain quality assurance metrics for the organization.Act as a customer contact for QA related issues/initiatives as needed.Partner with QA management to develop, distribute and maintain regular management reports.Read, interpret, and communicate technical documents, and regulations.Maintain site CAPA system for handling complaints and non-conformancesWrite and maintain work instructions, SOPs, and customer specific processes and ensure team is trained on applicationsMaintain document and change control with all regulated documents

Required Education and Experience

Bachelor’s degree in a related field or 3+ years relevant work experience, required3+ years of relevant experience in a regulated environment such as FDA, Health Canada etc., required1+ years of supervisory experience (preferably supervising/managing a quality system in a complex/matrix organization), requiredCertification related to quality control (RAC, Six-Sigma, etc.), preferred

Our Organization has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.

Our Organization is an equal opportunity employer.