Quality Systems Specialist - Training Specialist

Actalent

United States

Hybrid

USD 48,000 - 62,000

Full time

8 days ago
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Job summary

Actalent seeks a Quality Systems Specialist Training Specialist to support PDM and Quality by designing risk-based, compliant training solutions in regulated environments. The role emphasizes inspection-ready training and cross-functional collaboration in a hybrid Foster City, CA setting.

The position focuses on managing LMS activities, training data, and curricula while balancing regulatory expectations with operational efficiency to deliver scalable programs.

Qualifications

  • 35+ years of experience in a regulated pharmaceutical, biotech, or medical device environment.
  • Experience in GxP training, Quality Systems, or compliance-driven learning.
  • Working knowledge of pharmaceutical Quality Systems and GxP training requirements.
  • Ability to apply risk-based thinking to training requirements.

Responsibilities

  • Partner with SMEs and leaders to assess training impact for governance procedures.
  • Apply risk-based methods to determine training requirements and audiences.
  • Assess and optimize training curricula and role-based assignments.
  • Translate learning strategy into compliant, inspection-ready deliverables.
  • Serve as Training SME advising cross-functional partners on training approaches.
  • Independently analyze cross-functional training impacts and propose solutions.
  • Support design and execution of site/functional training programs for compliance.
  • Develop, maintain, and govern training content, records, and metrics.

Skills

LMS management
Risk-based thinking
GxP training
Quality systems
Cross-functional collaboration
Data-driven decisions
Attention to detail
Training effectiveness
Regulatory compliance

Tools

Learning Management System (LMS)
Training data & metrics

Job description

Job Title: Quality Systems Specialist Training Specialist
Job Description

The Training Specialist plays a key role in supporting PDM and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and optimizing training curricula aligned with job roles and Quality System expectations. In this role, you partner cross-functionally to translate learning strategy into effective, inspection-ready training deliverables that balance regulatory compliance with operational efficiency.

Responsibilities
  • Partner with Subject Matter Experts, Business Process Owners, and functional leaders to assess training impact for new or revised governance procedures.
  • Apply a risk-based approach to determine training requirements, target audiences, and delivery methods for quality and compliance-related training.
  • Assess and optimize training curricula and role-based assignments to ensure alignment with functional responsibilities and Quality System expectations.
  • Translate learning strategy into compliant, inspection-ready training deliverables in collaboration with project managers and key stakeholders.
  • Serve as a Training Subject Matter Expert, advising cross-functional partners on effective, compliant training approaches and solutions.
  • Independently analyze complex, cross-functional training impacts and propose practical, defensible training solutions that support compliance and operational efficiency.
  • Support the design and execution of site or functional training programs that meet compliance goals and promote operational excellence.
  • Assist in the development, maintenance, and governance of training content, records, and metrics in accordance with internal policies, procedures, and applicable regulations.
  • Support administration and ongoing maintenance of the Learning Management System, including using training data and metrics to inform decisions and drive continuous improvement.
  • Coordinate training-related activities and projects within defined objectives, timelines, and quality standards.
  • Proactively identify opportunities to improve training efficiency, enhance learner experience, and increase overall training effectiveness.
  • Partner with department heads and stakeholders to evaluate, refine, and implement training plans that meet business and regulatory needs.
  • Provide additional training and quality support as directed, ensuring that learners receive the guidance and resources they need at the right time.
Essential Skills
  • 35+ years of experience in a regulated pharmaceutical, biotech, or medical device environment.
  • Direct experience in GxP training, Quality Systems, or compliance-driven learning.
  • Working knowledge of pharmaceutical Quality Systems and GxP training requirements.
  • Demonstrated ability to exercise independent judgment on training impact and compliance-driven learning decisions.
  • Proven experience applying risk-based thinking to training requirements while balancing regulatory expectations and operational needs.
  • Strong attention to detail with the ability to anticipate downstream impacts to curricula, learners, and compliance.
  • Effective communication skills with the ability to influence and constructively challenge stakeholders using data-driven rationale.
  • Working knowledge of Learning Management System functionality, training data, and training metrics.
  • Ability to multi-task and manage multiple training initiatives concurrently.
  • Quality-minded approach with a focus on accuracy, consistency, and continuous improvement.
  • Customer-service orientation, demonstrating genuine care for supporting the needs of internal customers and learners.
Additional Skills & Qualifications
  • Experience in training development and training instruction, including designing and delivering engaging learning solutions.
  • Experience as a quality systems specialist or in a similar role, with an understanding of who needs training and when within a regulated environment.
  • Ability to partner effectively with department heads and stakeholders to evaluate and refine training plans.
  • Demonstrated willingness to learn, adapt, and embrace new approaches to training beyond traditional read-and-understand methods.
  • Strong interpersonal skills, with the ability to build trust and collaborate across functions and levels.
  • Risk-based decision-making mindset, balancing compliance requirements with operational efficiency and learner needs.
Work Environment

This position operates in a hybrid work environment, with on-site presence expected on Tuesday, Wednesday, and Thursday and remote work flexibility on other days. You collaborate closely with cross-functional teams in PDM and Quality, using a Learning Management System and training data to manage curricula and track metrics. The role focuses on inspection-ready, compliance-driven training within a regulated pharmaceutical, biotech, or medical device setting, supporting a culture of operational excellence and continuous improvement.

Job Type & Location

This is a Contract position based out of Foster City, CA.

Pay and Benefits

The pay range for this position is $35.00 - $45.00/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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Foster City,CA.

Application Deadline

This position is anticipated to close on Sep 29, 2026.

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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

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

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

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