Quality Assurance Specialist I

Panda International; Gaithersburg (MD); In loco; USD 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

Panda International is looking for a Quality Assurance Associate to provide essential support for GMP manufacturing operations in Gaithersburg, Maryland. This role requires real-time compliance with cGMP standards on the production floor, focusing on QA oversight and batch record review.

The ideal candidate will have a Bachelor’s degree in a related field and some experience in a regulated environment. Strong attention to detail and collaboration skills are vital for ensuring high-quality production outcomes.

Competenze

• 0-2 years of experience in a regulated biotech, pharmaceutical, or manufacturing environment.
• Foundational understanding of cGMP and regulatory expectations.
• Prior exposure to QA, QC, or GMP manufacturing environments.

Mansioni

• Provide Quality Assurance support to GMP manufacturing operations.
• Ensure real-time compliance with cGMP requirements and internal procedures.
• Focus on on-the-floor QA oversight and batch record review.

Conoscenze

Attention to detail

Collaboration

Understanding of cGMP

Formazione

Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related discipline

Descrizione del lavoro

Quality Assurance Associate – Manufacturing (On-the-Floor QA)

This role provides Quality Assurance support to GMP manufacturing operations within a regulated biopharmaceutical environment. The position is embedded directly on the production floor, ensuring real-time compliance with cGMP requirements, internal procedures, and regulatory expectations. The role focuses on on-the-floor QA oversight, batch record review, product disposition activities, and investigation support. You will work closely with Manufacturing, Quality Control, and technical teams to ensure high-quality production outcomes and continuous improvement across operations.

Essential Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related discipline
• 0–2 years of experience in a regulated biotech, pharmaceutical, or manufacturing environment
• Foundational understanding of cGMP and regulatory expectations
• Prior exposure to QA, QC, or GMP manufacturing environments

Preferred Requirements

• Experience performing on-the-floor QA oversight
• Experience reviewing executed batch records and GMP documentation
• Exposure to deviation management, investigations, and CAPA processes
• Experience with AQL inspections and line clearance checks
• Ability to collaborate effectively with Manufacturing, QC, and MSAT teams
• Strong attention to detail and documentation accuracy
• Flexibility to support shift work and 24/7 operations

Practicalities

• Start Date: TBD
• Contract Duration: Permanent
• Location: On-site