Quality Assurance Specialist II
: Job Details :

Job Title: Quality Assurance Manufacturing Specialist II

Location: Pennsylvania, USA

About the Role:

We are seeking a Quality Assurance Manufacturing Specialist II to join our team as we prepare this site for commercialization. This role will be vital in establishing and enforcing quality systems, supporting production targets, and ensuring top-tier compliance as we transition the facility to commercial readiness.

Key Responsibilities:

• Provide on-the-floor support through QA procedures, ensuring smooth shop floor operations.
• Offer quality guidance for deviations, technical documentation, process optimization, and audit readiness.
• Review minor deviations, recommend CAPAs, and ensure thorough investigations and action steps.
• Collaborate with cross-functional departments to ensure timely QA review and batch disposition.
• Compile batch documentation and generate Certificates of Conformance to meet client timelines.
• Monitor trends in data and identify key issues for quality improvements.
• Maintain GMP standards and support ongoing quality improvement systems.
• Review batch records and facilitate document changes for SOPs as needed.

Qualifications:

• Bachelor's degree in a scientific or commercial field.
• 3-5 years of experience in the pharmaceutical or biopharmaceutical industry.
• 1-3 years in a quality-focused role within the industry.
• Strong communication, problem-solving, and project management skills.

Why Join Us?

This is an exciting opportunity to be part of a team focused on bringing a manufacturing site to commercial readiness. As the company gears up for commercialization, you'll play a key role in quality assurance processes that will support this critical phase.

Equal Opportunity Statement:

We are an Equal Opportunity Employer, dedicated to inclusivity and diversity in the workplace. All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability, veteran status, or any other protected category.

If you're passionate about quality and compliance and ready to contribute to a site on the brink of commercialization, we encourage you to apply!