Job Details
Posted 26 August, 2026
Job Id: 630430
Quality System Specialist
Job Description
Target PR Range: 38-49/hr
*Depending on experience
Position Summary
The Quality Systems Specialist supports Quality Systems operations through the administration and coordination of document control and change control activities. This role is responsible for routing controlled documents through established approval workflows, maintaining document records, supporting change control processes, and helping ensure documentation complies with applicable quality standards, procedures, and regulatory requirements.
The specialist works closely with document authors, business process owners, Quality, Operations, Training, and other stakeholders to facilitate timely review, approval, implementation, and archival of quality documents and change records. The role requires strong attention to detail, effective follow-up, and experience working within regulated quality systems.
Key Responsibilities
Document Control Administration
* Manage the end-to-end routing of controlled documents through established review and approval workflows.
* Coordinate document reviews with subject matter experts, process owners, and approvers.
* Monitor document status and follow up with stakeholders to support adherence to approval timelines.
* Review document submissions for completeness, formatting, version control, and procedural requirements.
* Maintain document control records and support accurate document lifecycle management.
* Support document issuance, publication, archival, and obsolescence activities.
* Assist document authors with templates, formatting standards, and document management best practices.
Change Control Support
* Facilitate administrative activities associated with change control records within the electronic Quality Management System (eQMS).
* Review change requests for completeness and required supporting documentation before workflow progression.
* Route change controls through required review and approval paths.
* Track approvals, implementation activities, action items, and closure milestones.
* Monitor change control progress and communicate status updates to stakeholders.
* Support Change Review Board or similar governance meetings by preparing materials, documenting minutes, and tracking actions.
* Confirm associated document updates are appropriately linked to approved change records.
Qualifications
Education
* Associate degree required; bachelor’s degree preferred in Quality, Life Sciences, Business Administration, or a related field.
Experience
* 5+ years of experience in document control, quality systems, records management, and change control within a regulated pharmaceutical, biotechnology, medical device, or similar environment.
* Strong hands-on experience with Veeva Vault QualityDocs and other EDMS/eQMS platforms (TrackWise, MasterControl, SharePoint, or similar).
* Extensive experience coordinating change controls and cross-functional document approval workflows.
* Demonstrated ownership of GMP-controlled documentation and records management processes.
Knowledge and Skills
* Strong attention to detail, organization, and follow-through.
* Ability to manage multiple priorities and deadlines simultaneously.
* Strong knowledge of document control principles, records management practices, change control processes, and quality system requirements.
* Understanding of Good Documentation Practices and regulated quality environments.
* Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.
* Strong written and verbal communication skills.
* Ability to collaborate effectively across functional areas and appropriately escalate issues.
Key Contract Deliverables
* Timely routing and processing of controlled documents through approval workflows.
* Accurate tracking and administration of change control records and associated actions.
* Maintenance of complete, organized, and audit-ready documentation.
* Consistent communication of document and change control status to stakeholders.
* Support for quality system compliance and process improvement activities during the contract period.
Preferred Systems Experience
* Experience with additional document and quality management platforms such as TrackWise, MasterControl, SharePoint, or similar EDMS/eQMS systems.
*CO/NYC candidates might not be considered
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
