Quality Assurance Specialist
4 weeks ago
Quality Assurance Specialist
Job Description
As a Quality Assurance Specialist at Actalent, you will be responsible for ensuring compliance with cGMP and cGTP regulations in pre-clinical, clinical, and commercial manufacturing. Your duties will include performing raw material inspections, issuing and maintaining cGMP and cGTP documentation, and conducting line clearance prior to manufacturing operations. You will also be responsible for building quality into all aspects of your work by maintaining compliance to all quality requirements.
Responsibilities:
- Perform raw material inspections and raw material release according to SOPs and in compliance with all regulatory standards.
- Issue and maintain all cGMP and cGTP documentation, including but not limited to logbooks and training binders.
- Conduct line clearance prior to manufacturing operations.
- Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
- Ensure compliance with all FDA and Worldwide Quality & Compliance regulations as applicable to the job function.
Requirements:
- Strong understanding of cGMP and cGTP regulations.
- Excellent communication and interpersonal skills.
- Ability to work in a team-oriented environment and with clients.
- Must be able to work during the weekend, holidays, and as required by the company.
- May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
- Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
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.
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We maintain an inclusive environment through persistent self-reflection, build a culture of care, engagement, and recognition with clear outcomes, and ensure growth opportunities for our people.
We are 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.
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