Quality Systems Specialist II

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

Quality Systems Specialist II

Duration: 6-Month Contract with potential for extension or conversion

About the Role

We are seeking a Quality Systems Specialist II to support and strengthen our Quality Management System (QMS) within a regulated pharmaceutical manufacturing environment. This role is ideal for a quality professional with experience in document control, training administration, CAPA management, audits, and regulatory compliance. As a key member of the Quality team, you will collaborate cross-functionally with Operations, Manufacturing, Regulatory Affairs, and Leadership to ensure compliance with cGMP, ICH, ISO, and customer requirements while driving continuous improvement initiatives across the organization.

Key Responsibilities

• Maintain and improve the Quality Management System (QMS) to support regulatory compliance and operational excellence.
• Manage document control activities, including creation, revision, routing, approval, and maintenance of SOPs and controlled documents.
• Administer employee training records and training matrices, ensuring alignment with current procedures and regulatory requirements.
• Ensure compliance within electronic document management and quality systems.
• Process and manage quality events, including CAPAs, deviations, change controls, and customer complaints.
• Support internal audits, external audits, and regulatory inspections, including preparation, participation, and follow-up activities.
• Investigate quality issues, perform root cause analysis, and support implementation of corrective and preventive actions.
• Manage customer quality agreements and support supplier qualification activities.
• Maintain audit-ready documentation and records.
• Assist with the implementation, optimization, and ongoing administration of electronic Quality Management Systems (eQMS), including MasterControl or similar platforms.
• Partner with Quality, Manufacturing, Operations, and Regulatory teams to drive continuous improvement and compliance initiatives.

Required Qualifications

• Bachelor's degree in a scientific discipline or related field.
• 3+ years of Quality Assurance, Quality Systems, or related experience within a cGMP, GxP, ISO-regulated, pharmaceutical, biotechnology, or medical device environment.
• Strong understanding of Quality Management Systems (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 and external audits and regulatory inspections.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Experience with MasterControl or other electronic Quality Management Systems (eQMS).
• Pharmaceutical manufacturing experience strongly preferred.
• Experience supporting supplier quality programs and customer quality agreements.
• Internal auditing experience.
• Demonstrated ability to manage multiple priorities in a fast-paced, regulated environment.

Why Join the team?

• Opportunity to make a visible impact within a growing life sciences organization.
• Broad exposure across Quality Systems, Document Control, Training, CAPA, Auditing, Supplier Quality, and Compliance functions.
• Collaborative, cross-functional environment with significant interaction across the business.
• Potential for contract extension based on performance and business needs.

If you're passionate about quality, compliance, and continuous improvement in a regulated environment, we'd love to hear from you.
Job Type & Location
This is a Contract position based out of Oceanside, CA.
Pay and Benefits
The pay range for this position is $28.50 - $35.61/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Job Type & Location
This is a Contract position based out of Oceanside,CA.
Application Deadline
This position is anticipated to close on Oct 30, 2026.
Workplace Type
This is a fully onsite position in Oceanside,CA.

The company is an equal opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
adjustment of the job application process or interviewing process due to a disability,
please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.