Quality Systems Specialist
Russell Tobin is partnering with a company in the life sciences industry to identify a Quality Systems Specialist for a 100% remote opportunity.
Additional Details:
- Location model: Remote
- Position Type: 6-month contract with potential to extend
- Pay range approved: $35/hr - $45/hr, depending on experience
- Shift: Standard schedule; no non-standard shifts required
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 designated approvers.
- Monitor document status and follow up with stakeholders to ensure timely completion of reviews and approvals.
- Review document submissions for completeness, formatting, version control, and compliance with established procedures.
- Maintain accurate document control records and support document lifecycle management.
- Coordinate document issuance, publication, archival, and obsolescence activities.
- Assist document authors with templates, formatting standards, and document management best practices.
Change Control Support
- Coordinate administrative activities related to change control records within an electronic Quality Management System (eQMS).
- Review change requests for completeness and required supporting documentation before advancing them through established workflows.
- Route change control records through the appropriate review and approval processes.
- Track approvals, implementation activities, action items, and closure milestones.
- Monitor change control progress and communicate status updates to relevant stakeholders.
- Support Change Review Board meetings by preparing materials, documenting meeting minutes, and tracking action items.
- Ensure associated document updates are appropriately linked to approved change control records.
Quality Systems and Compliance
- Maintain complete, accurate, organized, and audit-ready quality documentation.
- Follow Good Documentation Practices (GDP) and applicable quality system procedures.
- Support compliance with relevant regulatory requirements and internal quality standards.
- Identify documentation gaps, workflow delays, and potential process issues, escalating them as appropriate.
- Contribute to quality system process improvement initiatives and effective records management practices.
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.
- Hands-on experience with Veeva Vault QualityDocs and other electronic document management systems (EDMS) or electronic Quality Management Systems (eQMS).
- Experience with platforms such as TrackWise, MasterControl, SharePoint, or similar systems.
- Extensive experience coordinating change controls and cross-functional document review and approval workflows.
- Demonstrated ownership of GMP-controlled documentation and records management processes.
Knowledge and Skills
- Strong understanding of document control principles, records management, change control processes, and quality system requirements.
- Familiarity with Good Documentation Practices (GDP) and regulated quality environments.
- Excellent attention to detail, organizational skills, and follow-through.
- Ability to manage multiple priorities, competing deadlines, and concurrent workflows.
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and Teams.
- Strong written and verbal communication skills.
- Ability to collaborate effectively with cross-functional teams and escalate issues when necessary.
APPLY NOW!
Russell Tobin is a professional recruitment and staffing advisory firm that connects job seekers and employers across various industries. We are a staffing arm of Pride Global. Affiliates include Russell Tobin, Pride health, Pride Now and Pride One.
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For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.
Equal Employment Opportunity
PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.
Fair Chance Employment
PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.
Accommodations
We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.
Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.
Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.
