Quality Assurance Specialist (Temp)

Quality Assurance Specialist (Temp)

Location: Remote

Job Status: Non-Exempt, full-time

Reports to: Director of Quality and Operational Excellence

Date Prepared: 10/14/2026

TMRW, part of the Reprotech family of companies, develops technology and systems that support the safe identification, management, storage, and handling of reproductive cells. Reprotech provides long-term reproductive tissue cryostorage services. This temporary position will support Quality and compliance activities across the organization based on project and organizational needs.

Position Summary

The Quality Specialist will support quality and compliance activities associated with the Reprotech/TMRW merger, organizational changes, and relocation of the corporate headquarters. The role will assist with updates to controlled documents, facility registrations, certifications, technical documentation, notified body records, and other quality and regulatory records impacted by changes to company structure, responsibilities, and corporate address. The specialist will also support ISO 13485 audit-readiness and certification activities related to the headquarters move, coordinate required updates with internal stakeholders and external organizations, maintain project tracking, and help ensure transition activities are completed accurately and on schedule.

Key Duties & Responsibilities

• Coordinate review and revision of controlled documents impacted by the merger, organizational changes, and headquarters relocation, including approximately 75 documents identified for address changes and more than 200 requiring review for organizational impacts.
• Maintain the impact-assessment and remediation tracker for affected documents, registrations, certifications, technical files, owners, required actions, due dates, dependencies, and completion status.
• Draft administrative and organizational revisions, including corporate address, company or legal-entity references, department names, job titles, roles and responsibilities, reporting relationships, and document ownership; coordinate substantive revisions with document owners and subject-matter experts.
• Initiate, route, and track document changes through the eQMS, including approval follow-up, implementation activities, effective dates, and closure.
• Review related procedures, work instructions, forms, templates, training materials, and referenced documents to identify consequential updates and maintain consistency across the QMS.
• Assist with updates to facility registrations, licenses, certifications, notified body records, and other external compliance records affected by the headquarters relocation, organizational changes, or merger.
• Support updates to technical documentation and technical files where company, site, address, organizational, or responsibility changes require revision.
• Support ISO 13485 certification and audit-readiness activities associated with the headquarters relocation, including external communications, evidence collection, document review, readiness tracking, and closure of identified gaps or actions under the direction of Quality and Regulatory leadership.
• Organize and maintain objective evidence of completed transition activities, including approvals, correspondence, submissions, updated certificates, registration confirmations, and implementation records.
• Prepare routine status summaries and escalate overdue actions, dependencies, inconsistencies, or other risks that could affect regulatory, certification, audit, or project timelines.
• Use approved productivity and AI tools appropriately, to support efficient document drafting, revision, proofreading, grammar, formatting, and consistency checks while maintaining required review and approval controls.
• Provide other Quality System, audit, documentation, and compliance support related to the organizational transition as assigned.

Education and Experience Requirements

• Bachelor's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or a related field is preferred; an equivalent combination of education and relevant experience may be considered.
• Approximately five to seven years of experience in Quality Assurance, Quality Systems, Document Control, Regulatory Affairs, or a related function in a regulated environment is preferred.
• Experience with controlled documents, change control, document remediation, and electronic quality management systems is strongly preferred.
• Familiarity with ISO 13485 and regulated quality systems is preferred; medical devices, biologics, tissue banking, laboratory, or other life-science experience is beneficial.
• Experience supporting audits, certification activities, regulatory registrations, site changes, QMS harmonization, merger integration, or large-scale document remediation is preferred.

Knowledge, Skills, and Abilities

• Strong organizational and project-coordination skills, with the ability to manage a high volume of concurrent document and compliance updates and maintain accurate status tracking.
• Strong attention to detail and ability to identify inconsistencies across controlled documents, records, systems, registrations, and other compliance information.
• Ability to interpret defined quality and regulatory requirements and translate them into clear action items, while recognizing when questions require escalation.
• Strong written communication, technical writing, proofreading, and document-editing skills.
• Ability to work independently, manage priorities and deadlines, and coordinate effectively with Quality, Regulatory, Operations, Engineering, HR, and other internal and external stakeholders.
• Proficiency with Microsoft Word, Excel, Outlook, SharePoint, Salesforce, and similar business applications; experience with Propel or another eQMS is preferred.
• Comfort using approved AI tools to support document drafting, revision, proofreading, grammar, formatting, and consistency checks while applying appropriate judgment and maintaining Quality review and approval requirements.

Position Details

• Temporary, full-time assignment expected to last approximately six months, with the possibility of extension based on project or organizational needs.
• Fully remote position available to candidates located within the United States.
• Priorities may shift as regulatory, certification, audit, relocation, and organizational deadlines evolve.

Reasonable accommodations may be provided to qualified individuals with disabilities to enable them to perform the essential functions of the position.