QA Specialist II – Quality Operations

• Location: Houston, TX
• Employment Type: Full-Time

About the Role

• We are seeking a QA Specialist II – Quality Operations to join our growing team in Houston, TX. In this role, you will represent the Quality Assurance department by ensuring compliance with all regulatory and cGMP requirements. You will support manufacturing operations, provide on-the-floor QA oversight, review GMP documentation, and contribute to investigations, CAPAs, and change controls. This position is ideal for individuals with early-career GMP experience looking to expand their impact in a dynamic biopharmaceutical environment.

Key Responsibilities

• Ensure compliance with ISO, GMP, and other relevant quality system requirements.
• Provide oversight and support for CAPAs and minor deviations.
• Perform routine QA walkthroughs and collaborate with manufacturing and support teams to resolve issues.
• Support QA presence on the manufacturing floor.
• Review and approve Master Batch Records and executed records for batch disposition.
• Conduct buffer/media release as needed.
• Track and maintain quality records; ensure cGMP compliance throughout all activities.
• Perform additional duties as assigned.

Key Stakeholder Collaboration

• You will regularly partner with:
  • Manufacturing leadership
  • Facilities & Engineering
  • Quality Control (QC) teams

Qualifications

Education

• Bachelor’s degree required, preferably in Life Sciences.

Experience

• 0–4 years of GMP experience within biologics or pharmaceutical manufacturing.
• Working knowledge of equipment/facility qualifications, GDP, and GMP environments.

Skills

• Familiarity with US/EU regulations.
• Strong understanding of biopharmaceutical manufacturing processes.
• Experience with validation activities (equipment/facilities/utilities).
• Excellent communication, critical thinking, and documentation skills.

Core Competencies

• Agility: Ability to adapt quickly to shifting priorities and support cross-functional needs.
• Business Acumen: Communicate timelines, risks, and resource needs effectively.
• Collaboration: Work constructively and professionally with cross-functional teams.
• Customer Focus: Communicate clearly with internal stakeholders; respond to requests professionally.
• Driving Results: Proactively identify gaps and implement workflow improvements.
• Leadership: Make informed decisions; demonstrate safety-first behavior.

Work Environment & Physical Requirements

• Regular office hours; <10% travel.
• Office and controlled manufacturing environments requiring walking, standing, climbing, gowning, and occasional lifting (up to 50 lbs).
• Must comply with all site safety policies and cGMP requirements.
• Requires frequent interaction with stakeholders and strong analytical/critical-thinking abilities.

Why Join Us?

• You’ll be part of a mission-driven team supporting cutting-edge cell and gene therapy manufacturing. We offer professional growth opportunities, a collaborative environment, and a culture that values safety, quality, and innovation

This is a Contract to Hire position based out of Houston, TX.

The pay range for this position is $30.77 - $51.28/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 fully onsite position in Houston,TX.

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

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $31 - $51