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Quality Assurance Specialist

Apex Systems Inc

Quality Assurance SpecialistApex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients' digital visions.Apex has an opportunity for a Quality Assurance Specialist. This role is 25 hours per week, Monday-Friday. This is a 3-month contract.With our client, you will play a critical role in ensuring that our products meet the highest quality standards before reaching customers or progressing through the manufacturing process. As a QA Specialist II, Product Release, you will be responsible for reviewing and auditing quality documentation, supporting product disposition activities, and helping maintain compliance with applicable regulatory requirements and quality standards. This role requires a detail-oriented professional who thrives in a regulated environment, enjoys collaborating across functions, and is passionate about continuous improvement and product quality.Your tasks include:Review and audit device history records, batch records, and other quality documentation to ensure compliance with internal procedures, cGMP requirements, ISO standards, FDA regulations, and other applicable quality requirements.Perform product release activities and disposition decisions for materials and finished goods approved for manufacturing use or customer distribution.Support the control of products throughout their lifecycle, including review of deviations, nonconformities, and related quality records.Partner with Operations and cross-functional teams to resolve documentation issues and ensure compliance with quality requirements.Contribute to continuous improvement initiatives by identifying opportunities to enhance Product Release processes, procedures, and efficiency.Participate in departmental metric collection, analysis, and reporting to support quality objectives and operational excellence.Serve as a quality resource for training, cross-functional collaboration, and quality-related inquiries across the organization.Your profile:Bachelor's degree in a scientific discipline or equivalent scientific experience, with a minimum of 2 years of professional experience, preferably within a regulated industry.Working knowledge of cGMP, Quality System Regulations (QSRs), ISO standards, and other applicable regulatory requirements.Strong attention to detail and auditing skills, with the ability to accurately review complex documentation and data.Demonstrated ability to manage multiple priorities, work independently, and remain flexible in a fast-paced manufacturing environment.Effective communication and interpersonal skills, with the ability to collaborate and build relationships across all organizational levels.Proficiency with Microsoft Office applications; experience with ERP systems and/or Electronic Document Management Systems (EDMS) is advantageous.Team-oriented mindset with strong organizational skills and the ability to support demanding projects while maintaining quality and compliance standards.Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Vacancy posted 2 days ago
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