Senior Quality Assurance Specialist - Computer System Validation (4-6 yrs)

Primary Purpose :

The QA Specialist - Security and Computer Systems (CSV) will provide direct support to Emmes' proprietary software The Senior QA Specialist assists QA management in guiding the direction of the Quality Management System. This individual works with project and department leaders to assist projects and departments with adherence to applicable regulations, industry standards, and project requirements. The Senior QA Specialist mentors less experienced team members.

Clinical Role :

The Senior Quality Assurance Specialist supports the QA Department by conducting internal and vendor audits, assisting with client audits and regulatory inspections, and supporting with Quality Management System compliance management including management of CAPA, quality incident, changes to the Standards/ QMS. This role may focus on auditing specific aspects of the QMS, such as clinical sites, monitors, safety, or TMF.

Computer System Validation role :

The Senior Quality Assurance Specialist will support Emmes' proprietary and commercial off-the-shelf (COTS) software systems used in clinical trials, as well as IT security deliverables. This role involves auditing, developing, and implementing verification and validation (V&V) processes for both in-house and COTS software, and documenting these activities. The QA Specialist will also assist in internal audits of IT and information security processes to ensure compliance with GCP, NIST SP 800-53, FISMA, 21 CFR Part 11 / EU Annex 11, GAMP 5, internal SOPs, and industry standards.

Responsibilities :

- Conducts internal audits of projects, processes, clinical sites, monitors, deliverables, and departments of moderate to complex scope, requiring an in-depth evaluation and capacity to synthesize and apply information from one task or audit to another.

- Reviews documentation for accuracy and compliance (e.g., training records, test plans/scripts, CAPAs, quality incidents, audit reports, etc.).

- Reviews and tracks non-compliances, deviations, and CAPAs.

- Leads supplier/vendor qualification and evaluation.

- Leads client audits and regulatory inspections.

- Leads or participates in process improvement projects.

- Assists in or creates audit schedules for one or more portions of the Quality Management System (QMS).

- Writes and reviews corporate SOPs and policies.

- Conducts trainings as needed.

- As a subject matter expert, provides guidance or mentors and trains less experienced team members, with potential day-to-day oversight of some QMS activities or functions.

- Represents the Quality Assurance department at meetings or events with nominal assistance or oversight from Quality Management.

- May contribute to solutions for corporate and global QA initiatives and tasks.

- Performs other duties as assigned.

- May also need to perform the below activities based on the role :

- Review and audit information security and computer systems verification and validation processes to identify potential security gaps and non-compliance.

- Ensure items documented on the plans of action and milestones (POAM) are aligned to framework for security and privacy controls for information systems and organizations like the NIST SP 800-53 and others- as applicable.

- Review scan and evidence controls provided by Information Technology department to ensure identified vulnerabilities are appropriately remediated in specified timeframe

- Conduct periodic assessment of information security controls including remediation activities from FISMA/ ISO/ FEDRAMP/ other standard requisite audits.

Qualifications :

- Bachelor's degree in Life Sciences or a related scientific field and 4 years related experience, or a Master's degree and 2 years related experience, or 6+ years of related experience for a Clinical QA OR Bachelor's degree in computer science, software engineering, or a related field, and 4 years related experience, or a Master's degree and 2 years related experience, or 6+ years of related experience in computer systems and / or information technology security auditing for a CSV QA role.

- Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO) with two to three years' of auditing experience in the relevant field.

- Experience working in a regulated environment (e.g., GxP, ISO) and Familiarity with SDLC validation tools, including testing strategies like SAST and DAST and their use in identifying security vulnerabilities based on the role

- Ability to prioritize critical tasks and provide a high level of responsiveness and timely service on a day-to-day basis as well as balance the unexpected needs of the company as they arise.

- Demonstrated organizational skills, high attention to detail, and ability to multi-task.

- Strong written and verbal communication as well as problem-solving skills.

- Microsoft Office proficiency.