Quality Specialist

Description:

Quality Specialist Overview: We are seeking a skilled and detail-oriented candidate who can help with in equipment validations for pharmaceutical manufacturing. The successful candidate will play a key role in ensuring compliance with industry regulations by executing and overseeing equipment qualification processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Cleaning Commissions, and Cleaning Validations. Additionally, this individual will be responsible for onboarding new equipment into the quality system.

1. Conduct IQ, OQ, and PQ activities for manufacturing equipment.
2. Lead and participate in FATs and SATs to ensure equipment meets specified requirements.
3. Oversee and manage cleaning commissions and cleaning validations for equipment in compliance with industry standards.
4. Quality System Onboarding:
   1. Facilitate the integration of new equipment into the quality management system.
   2. Collaborate with cross-functional teams to ensure seamless onboarding processes.
   3. Develop and maintain documentation related to equipment validation and quality system onboarding.
5. Compliance and Documentation:
   1. Ensure all equipment activities adhere to relevant regulatory guidelines.
   2. Maintain accurate and up-to-date documentation for validation processes.
   3. Assist in the preparation for audits and inspections related to equipment validations.

Skills:

Quality Control, Documentation, Sciences, Batch Record Review, GMP, Biology, IQ, PQ, FATs, SATs, Cleaning validation, equipment calibration, pharmaceutical

Additional Skills & Qualifications:

• BS in Chemistry or Biology is best. Would take a candidate with a material science, physics or chemical engineering degree.
• Minimum of 1-2 years of experience in pharmaceutical manufacturing industry or related GMP industry within quality.
• Familiarity with regulatory requirements and guidelines for pharmaceutical manufacturing.
• Strong working knowledge of Microsoft Office suites, including Word, Excel, Teams, and Outlook.
• Excellent organizational and communication skills.
• Ability to work collaboratively in a cross-functional team environment.

Experience Level:

Entry Level

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.

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.