Job Title: QA Specialist

Job Description

The Quality Risk Assessment Specialist is responsible for identifying, evaluating, and managing risks that could impact the quality of products or services. The individual will conduct assessments, collaborate with cross-functional teams, and implement risk management processes to ensure compliance with regulatory standards and company policies.

ResponsibilitiesIdentify quality risks related to manufacturing processes, product development, supply chain, and regulatory compliance.Evaluate the likelihood and severity of identified risks using risk assessment techniques such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).Develop and implement risk mitigation strategies to reduce or eliminate quality-related risks.Work with cross-functional teams to ensure action plans are executed and monitored.Document the results of risk assessments, including the identified risks, risk ratings, and mitigation strategies.Ensure proper record-keeping and documentation in compliance with industry standards and regulations (e.g., ISO, FDA, or GMP).Ensure risk management practices comply with relevant quality management standards, regulations (such as FDA, ISO 9001, and GMP), and industry best practices.Support continuous improvement initiatives by identifying areas for improvement based on risk analysis and trends.Facilitate corrective and preventive action (CAPA) processes when needed.Work closely with various teams (e.g., R&D, operations, regulatory affairs) to ensure risks are properly identified and mitigated across the product lifecycle.Provide training to staff on risk management tools and techniques.Prepare and present risk assessment findings, updates, and trends to management and regulatory bodies.Essential SkillsExperience with regulatory audits and inspections (e.g., FDA, ISO).Knowledge of statistical process control (SPC) and data analysis tools.Proficiency with risk management software (e.g., Windchill, TrackWise).Strong analytical and problem-solving skills.Familiarity with risk assessment tools (e.g., FMEA, Risk Priority Number (RPN), Fault Tree Analysis).Proficient in quality management systems (QMS) and regulatory frameworks.Excellent communication skills (both written and verbal).Ability to work cross-functionally and independently.Strong organizational skills and attention to detail.Additional Skills & QualificationsBachelor’s degree in a relevant field (e.g., Engineering, Life Sciences, Pharmaceutical Sciences, or Quality Management).Advanced certifications in Quality Management (e.g., Six Sigma, ASQ Certified Quality Engineer (CQE)) are a plus.5-10 years of experience in a quality assurance or risk management role, preferably in a regulated industry (e.g., pharmaceuticals, medical devices, food safety).Manufacturing experience.Experience with microbiology, aseptic processing, and technical writing.Work Environment

Shift: Monday - Friday, 8:00 AM - 5:00 PM. Mostly work onsite but could have some hybrid potential once established.

Pay and Benefits

The pay range for this position is $28.85 - $45.00/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)

Workplace Type

This is a fully onsite position in Saint Louis,MO.

Application Deadline

This position is anticipated to close on Feb 24, 2025.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.