Quality Systems Specialist

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

Job summary

Actalent is seeking a Quality Systems Specialist to support and maintain the QMS in a regulated pharmaceutical manufacturing environment. The role includes document control, SOP authoring, training records, and audits, with CAPA and change-control processing. It requires cross-functional collaboration to drive continuous improvement and compliance.

The position is a 6-month contract based in Carlsbad, CA, onsite, with a pay range of $28.50–$35.61 per hour and benefits eligibility as described.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 3-4 years of QA experience in a cGMP/GxP/ISO environment.
• Experience developing and improving quality systems in regulated manufacturing.
• Understanding CAPA, deviations, change controls, audits, and training systems.
• Procedures and quality systems meet cGMP/ISO/customer requirements.
• Strong technical writing skills.
• Investigate quality issues and perform root cause analysis.
• Experience with audits and regulatory inspections.
• Strong cross-functional collaboration and communication.
• Intermediate MS Office skills.
• Experience with electronic quality systems such as MasterControl preferred.
• Pharma or life sciences manufacturing experience highly preferred.

Responsibilities

• Maintain and manage the Quality Management System (QMS).
• Author and revise SOPs.
• Administer training records and matrices.
• Support internal and external audits.
• Process CAPAs, deviations, and change controls.
• Facilitate customer quality agreements and supplier qualification responses.
• Ensure compliance with cGMP, ISO, and customer requirements.
• Collaborate with Operations, Quality, Regulatory and leadership for continuous improvement.

Skills

Bachelor's degree in a scientific disc

Quality Assurance experience (3-4 yrs)

Quality systems improvement

CAPA, deviations, change controls

Procedures & quality systems conformed

Technical writing

Root cause analysis

Audits & regulatory inspections

Cross-functional collaboration

MS Office

MasterControl

Life sciences manufacturing experience

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

Job description

Job Title: Quality Systems Specialist

Job Description

The Quality Systems Specialist is responsible for supporting and maintaining the company's Quality Management System (QMS) within a regulated pharmaceutical manufacturing environment. This role involves managing document control activities, authoring and revising Standard Operating Procedures (SOPs), administering employee training records, supporting audits, processing quality events such as CAPAs, deviations, and change controls, and facilitating customer quality agreements. The position requires cross-functional collaboration with Operations, Quality, Regulatory, and leadership teams to drive continuous improvement and ensure quality system compliance.

Responsibilities

• Manage document control activities and maintain the Quality Management System.

• Author and revise Standard Operating Procedures (SOPs).

• Administer and maintain employee training records and training matrices.

• Support internal and external audits.

• Process quality events such as CAPAs, deviations, and change controls.

• Facilitate customer quality agreements and respond to supplier qualification requests.

• Ensure compliance with cGMP, ICH, ISO, and customer requirements.

• Collaborate with cross-functional teams to drive continuous improvement.

Essential Skills

• Bachelor's degree in a scientific discipline.

• 3-4 years of Quality Assurance experience in a cGMP, GxP, ISO-regulated manufacturing environment.

• Experience developing, maintaining, and improving quality systems in regulated manufacturing environments.

• Understanding of CAPA, deviations, change controls, complaints, audits, and training systems.

• Experience ensuring procedures and quality systems meet cGMP, ISO, and customer requirements.

Additional Skills & Qualifications

• Strong technical writing skills.

• Ability to investigate quality issues and perform root cause analysis.

• Excellent organizational and follow-up skills.

• Experience with audits and regulatory inspections.

• Strong communication skills and cross-functional collaboration.

• Intermediate Microsoft Office skills.

• Experience with electronic quality systems such as MasterControl preferred.

• Pharmaceutical or life sciences manufacturing experience highly preferred.

Work Environment

The work environment includes standard business hours from Monday to Friday, with an onsite office and manufacturing support environment. The role involves close collaboration with Quality, Operations, Manufacturing, Regulatory, and Management teams. It predominantly involves office-based work with extensive use of computer systems and documentation platforms in a fast-paced, regulated life sciences environment with shifting priorities and deadlines. This is a 6-month contract assignment.

Job Type & Location

This is a Contract position based out of Carlsbad, 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 Carlsbad, CA.

Application Deadline

This position is anticipated to close on Nov 9, 2026.

Workplace Type

This is a fully onsite position in Carlsbad,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.