Quality Systems Specialist II — QMS & Compliance Expert

Actalent; Oceanside (CA); On-site; USD 39,000 - 49,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Savings Account (HSA)

Transportation benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent is seeking a Quality Systems Specialist II for a 6-month contract in Oceanside, CA. You will support the Quality Management System in a regulated pharmaceutical environment, handling document control, training administration, CAPA, audits, and regulatory compliance.

You will collaborate across Operations, Manufacturing, Regulatory Affairs, and Leadership to ensure cGMP, ICH, ISO and customer requirements are met while driving continuous improvement.

Qualifications

• Bachelor's degree in a scientific field or related discipline.
• 3+ years in Quality Assurance or Quality Systems in cGMP/ISO-regulated environment.
• Strong understanding of QMS and regulatory requirements.
• Experience managing document control processes and controlled documentation.
• Working knowledge of CAPAs, deviations, change controls, audits, complaints, and training systems.
• Experience authoring, revising, and maintaining SOPs and quality documentation.
• Strong root cause investigation and problem-solving skills.
• Experience supporting internal/external audits and regulatory inspections.
• Excellent written and verbal communication skills.

Responsibilities

• Maintain and improve the QMS to support regulatory compliance and operational excellence.
• Manage document control activities for SOPs and controlled documents.
• Administer training records and matrices to ensure alignment with procedures.
• Ensure compliance within electronic document management and quality systems.
• Process and manage quality events including CAPAs, deviations, change controls, and complaints.
• Support internal and external audits and regulatory inspections, including prep and follow-up.
• Investigate quality issues, perform root cause analysis, and support CAPA implementation.
• Manage customer quality agreements and supplier qualification activities.
• Maintain audit-ready documentation and records.
• Assist with implementation and administration of eQMS (e.g., MasterControl).
• Collaborate with Quality, Manufacturing, Operations, and Regulatory teams to drive improvements.

Skills

QMS knowledge

Document control

CAPA management

Audits & inspections

SOP authoring

Root cause analysis

Training systems

MS Office

Regulatory compliance

Education

Bachelor's degree in a scientific discipline or related field

Tools

MasterControl or other eQMS

Job description

Actalent is seeking a Quality Systems Specialist II for a 6-month contract in Oceanside, CA. You will support the Quality Management System in a regulated pharmaceutical environment, handling document control, training administration, CAPA, audits, and regulatory compliance.

You will collaborate across Operations, Manufacturing, Regulatory Affairs, and Leadership to ensure cGMP, ICH, ISO and customer requirements are met while driving continuous improvement.