OneSource Account Quality Specialist

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

Basic Qualifications

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.

The annualcompensation range for this full-time position is $80,000 to $90,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job‑related skills, experience, and relevant education or training.

#J-18808-Ljbffr