Job#: 3035844

Job Description:

Role: Quality Assurance Specialist – Change Controls

Location: Remote

Type: Long Term Consultant

Summary 

We are seeking a Quality Assurance Specialist – Change Controls to support a global LabVantage LIMS implementation across manufacturing and quality operations. This role is responsible for authoring, coordinating, and executing GMP-compliant change controls to enable site readiness and successful system go-live. 

Key Responsibilities 

• Author and execute local change controls to support LabVantage deployment and go-live readiness. 
• Perform impact assessments (systems, data, processes, documentation, validation, training). 
• Coordinate with cross-functional stakeholders (QA, QC, IT, Validation, Operations) to drive timely approvals. 
• Maintain change control trackers and proactively identify risks, dependencies, and escalations. 
• Ensure compliance with GMP standards, site SOPs, and document control requirements. 
• Support go-live readiness and resolve change-related blockers impacting timelines. 

Deliverables 

• Completed change controls with impact assessments and supporting documentation. 
• Accurate tracking and reporting of change control activities. 
• Documentation meeting GMP compliance and approval criteria. 

Required Qualifications 

• 5+ years of experience in GMP Quality Assurance (pharma/biotech). 
• Proven experience authoring and executing change controls. 
• Working experience with LabVantage, specifically writing and supporting Change Control processes and documentation
• Strong knowledge of document control and regulated environments. 
• Experience managing multiple parallel workstreams and stakeholders. 
• Familiarity with quality systems (e.g., OneQMS, ALM, or similar). 

Preferred Qualifications 

• Experience supporting LIMS implementations, preferrably large LIMS migration experience.
• Exposure to CSV/validation processes in regulated environments. 
• Understanding of dependencies across data migration, integrations, and lab systems.

Core Competencies 

• GMP compliance mindset 
• Strong attention to detail and documentation quality 
• Stakeholder coordination and accountability 
• Risk identification and proactive escalation 

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth 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 ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at https://www.apexsystems.com/privacy-policy

Everforth Apex Benefits Overview: Everforth 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. Everforth 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, Everforth 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. Everforth 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 Everforth Apex team member can provide.

Everforth 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. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or 804-523-8228. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.