Quality Systems Specialist

Job Description

Job Description

Job Title: Quality Systems Training Specialist
Job Description

The Quality Systems Training Specialist supports Product Development and Manufacturing (PDM) and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and optimizing training curricula aligned to job roles and Quality System expectations. This role partners cross-functionally to translate learning strategy into effective, inspection-ready training deliverables that balance regulatory compliance with operational efficiency. The specialist acts as a key advisor on training approaches, helping the organization move beyond traditional read-and-understand models toward more engaging and effective learning experiences.

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 appropriate delivery methods.
• 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.
• Independently analyze complex, cross-functional training impacts and propose practical, defensible training solutions.
• Support the design and execution of site or functional training programs that meet compliance goals and support operational excellence.
• Assist in the development, maintenance, and governance of training content, training records, and training metrics in accordance with policies, procedures, and applicable regulations.
• Support administration and ongoing maintenance of the Learning Management System, including the use of training data and metrics to inform decisions and continuous improvement.
• Coordinate training-related activities and projects within defined objectives, scope, and timelines.
• Proactively identify opportunities to improve training efficiency, learner experience, and overall training effectiveness.
• Provide additional training and quality support as directed by leadership.
• Partner with department heads and stakeholders to evaluate, refine, and continuously improve training plans.
• Engage with learners and internal customers in a customer-service-oriented manner, demonstrating care, responsiveness, and a strong desire to support their needs.

• 6–8+ years of experience in a regulated pharmaceutical, biotechnology, or medical device environment.
• Direct experience in GxP training, Quality Systems, or compliance-driven roles.
• 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.
• High 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, including the use of training data and metrics.
• Experience in training development and training delivery or instruction.
• Ability to partner effectively with department heads and stakeholders to evaluate and refine training plans.
• Strong customer-service orientation and ability to build positive relationships with internal customers.
• Quality-minded approach with a focus on compliance, accuracy, and continuous improvement.
• Ability to make risk-based decisions and prioritize effectively in a regulated environment.
• Ability to manage multiple tasks and projects simultaneously while meeting deadlines.
• Willingness to learn, adapt, and embrace new training methodologies beyond traditional read-and-understand formats.

• Experience serving as a Training Subject Matter Expert in a regulated environment.
• Background in designing or supporting site or functional training programs that align with compliance and operational excellence goals.
• Experience optimizing role-based curricula and training assignments.
• Familiarity with using training metrics and data to drive continuous improvement.
• Demonstrated ability to work cross-functionally with Quality, operations, and other business functions.
• Interest in innovative, learner-centered training approaches and continuous enhancement of training effectiveness.

This position operates in a hybrid work environment, with on-site presence required on Tuesdays, Wednesdays, and Thursdays and remote work flexibility on other days, as business needs allow. The role collaborates closely with cross-functional teams in Quality and Product Development and Manufacturing, using a Learning Management System and other digital tools to manage training content, records, and metrics. The environment emphasizes regulatory compliance, operational efficiency, and continuous improvement, offering a long-term opportunity through April 1, 2028, for professionals who enjoy working with diverse stakeholders, balancing structure with innovation, and contributing to a robust Quality System.

Job Type & Location

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

The pay range for this position is $55.00 - $60.00/hr.

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)

This is a hybrid position in Foster City,CA.

This position is anticipated to close on Jun 5, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 View email address on ziprecruiter.com 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.