We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization’s biometric services and computer systems. This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security.  The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement.  Essential Functions and Responsibilities  1. Document & Process Auditing  - Conduct and/or host internal audits and vendor audits  - Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance  - Track and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions)  - Perform risk-based audit planning and inspection readiness assessments  2. SOPs, Policies and QMS Maintenance  - Review and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documents  - Ensure alignment with the company’s Quality Policy and applicable external regulations  - Ensure controlled documents are reviewed periodically and in a timely manner  - Document and manage deviations, nonconformances, and CAPAs  - Maintain quality records and support archiving in accordance with regulatory timelines   3. Training Management  - Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams  - Monitor overdue training, and follow up with individuals and their supervisors until completion  4. Computer System Validation Support  - Participate in validation planning and execution for internal and customer-facing systems  - Collaborate with software validation team and IT to review:  - Computer system validation plan (CVP)  - Functional/user requirements specifications and risk assessments  - Test scripts, validation protocols (IQ/OQ/PQ), and traceability matrices  - Test run reports and validations summary reports  - Review change requests, bug reports, and ensure re-validation as needed  - Ensure systems comply with 21 CFR Part 11 requirements, including audit trails, access control, and electronic signatures  5. Audit and Inspection Readiness  - Plan, execute, and document internal process audits, project/study audits, and vendor audits.  - Coordinate with IT and product teams to ensure systems and environments are audit-ready by confirming that the following activities are performed in accordance with SOPs:  - Systems are validated and reviewed in a timely manner  - Audit trails and system logs are monitored and reviewed  - Access reviews, system related exercises and tests, and security scans are performed periodically  - Coordinate with biometric teams to ensure services are performed in accordance with applicable regulations and EDETEK SOPs, including following QC processes, proper document versioning, review and approval, and appropriate documentation and sign-off for deviations  - Lead or assist in pre-inspection readiness for regulatory audits (e.g., FDA, EMA, MHRA).  - Track findings, respond to audit reports, manage CAPAs through resolution and effectiveness checks, and ensure timely completion with evidence retained for review  6. Cross-Functional Support  - Act as a QA liaison across departments, including Biometrics, Software Development, and IT/Security.  - Mentor junior QA team members by providing training and peer reviews.  - Represent QA in project meetings, product releases, and client quality discussions.  - Respond to client quality inquiries and due diligence questionnaires.  7. Continuous Improvement  - Lead or contribute to risk assessments for clinical projects, software systems, and vendor engagements.  - Identify quality gaps or inefficiencies and propose remediation or process improvement initiatives.  - Monitor and analyze quality metrics and trends (e.g., deviation rates, audit findings, CAPA effectiveness).  - Contribute to QMS improvement projects and ensure effective cross-functional adoption.

Job Opening: QA Specialist Location: Remote (Working US Hours - 9am-5pm EST) Type: Full-Time Salary: Paid in South African Rand (ZAR) Key Responsibilities - Conduct regular audits of clinical documentation, session notes, treatment plans, and assessments to ensure accuracy and compliance - Review submitted claims and supporting documentation for completeness and alignment with payer requirements - Identify errors, inconsistencies, or missing information and coordinate corrections with relevant team members - Ensure adherence to ABA best practices, company policies, and insurance guidelines - Monitor compliance with authorization requirements and service delivery standards - Collaborate with BCBAs, RBTs, and administrative staff to resolve documentation or billing discrepancies - Track and report on audit findings, trends, and areas for improvement - Develop and implement quality improvement initiatives and standard operating procedures (SOPs) - Provide feedback and training to staff on documentation quality and compliance standards - Stay up to date with changes in ABA regulations, payer requirements, and industry best practices

Title: Proofreader Location: - Richmond, VA, US Remote Employee Type: Contract Pay Range: $25 - $30 per hour Job Description: 5+ Years of experience Expertise in EndNote & SharePoint is required Expertise in Starting Point or other formatting rulers/tools like Global Summit Preferred Expected average up to 20 hours per week but it could (depending on the available work) be up to 37.5 Expectations of role: Proofreading of regulatory application sections for: (1) Narrative consistency (2) Grammar, punctuation, etc. (3) Conformance to client style guides Electronic software formatting of regulatory application sections Conversion of reference articles into publishable format Training background, formatting science documents & meet journal submission requirements for manuscripts EEO Employer 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. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join 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 ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide. Employee Type: Contract Remote: Yes Location: Richmond, VA, US Pay Range: $25 - $30 per hour

• Work closely with engineering and product owners to define test plans to help identify edge cases and critical user flows, write automated tests, and ensure high quality releases • Maintain and expand automation test framework and test processes to maintain a high level of product quality, while minimizing manual testing • Identify opportunities to improve QA strategy, remove gaps in coverage, and fix any test flakiness • Assist with building and maintaining test environments for the team • Identify and comprehensively document any bugs or areas for enhancement within the product • Suggest enhancements to both the functional and technical aspects of the product • Collaborate with team members on design techniques and coding standards