Bachelor's degree in a relevant field or equivalent professional experience with a minimum 3 years' experience in quality assurance within a GxP/pharmaceutical environment
Demonstrated experience with QMS processes (deviations, CAPA, change control, audits)
Strong knowledge of GMP and regulatory expectations
Must communicate fluently in English.
Ability to lead and influence without direct authority
Strong analytical, problem-solving, and decision-making skills
Excellent communication and stakeholder management skills
Preferred Characteristics
Strong working knowledge of Quality Management Systems in GxP environments
Proficiency in auditing (internal, supplier, and external inspection readiness)
Solid understanding of GMP regulations and Good Documentation Practices
Ability to balance proactive and reactive quality priorities in a dynamic environment
Proficiency in SAP, ServiceMax, SharePoint, Microsoft Excel, Word, and PowerPoint.
Certified Quality Auditor (CQA) or equivalent certification
Experience with Lean / Six Sigma methodologies
Experience working in customer-embedded or outsourced service environments
Working Environment
Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.).
Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.
Benefits
Health insuranceEquity / stock options
Additional Information
When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Job Title
OneSource Account Quality Specialist
Location(s)
GSK (Haleon) (Richmond) - Customer Site VA
Job Description
QMS Oversight & Compliance
Ensure effective implementation and adherence to the QMS and Quality Agreement
Monitor compliance, identify risks, and drive resolution of gaps
Partner with customer quality to maintain and update the Quality Agreement
Quality Leadership & Coordination
Act as the primary on-site quality SME and escalation point
Lead and coordinate quality activities across the account team
Promote a strong quality culture and influence without direct authority
Auditing & Inspection Readiness (Proactive Focus)
Plan and conduct internal, supplier, and process audits
Support customer, self-inspections, and regulatory inspections
Track audit findings, non-conformances, and CAPA effectiveness
Deviation, CAPA & Change Control (Reactive Support)
Oversee and support investigations, root cause analysis, and CAPA
Ensure timely closure of quality events with minimal operational impact
Review and approve quality records in line with delegated authority
Training & Quality Awareness
Own the site quality training program with site leadership
Deliver GMP and QMS training and ensure compliance and effectiveness
Drive awareness and accountability for quality across all site employees
Supplier Quality Oversight
Support supplier qualification, audits, and performance monitoring
Ensure supplier compliance with QMS and Quality Agreement
Address supplier-related quality issues with stakeholders
Continuous Improvement
Support delivery of the site quality plan and improvement initiatives
Analyze quality trends and drive actions to enhance performance
Report on quality metrics and audit outcomes to stakeholders
Perkinelmer · Gsk (haleon) (richmond) - Customer Site, VA