QC RAW MATERIALS SPECIALIST - Capricor Inc

Position: Quality Control - Raw Materials Specialist

A position is immediately available in our Quality Control (QC) group for a Raw Materials Specialist to focus on the testing and release of incoming raw materials at the Capricor Therapeutics San Diego/Los Angeles facilities. This role will collaborate with the Material and Supply Chain Department to ensure the timely and compliant testing of materials for the QC and Manufacturing (MFG) departments. Raw materials tested may include components for biologics, cell therapies, and regenerative products. We are seeking a highly motivated candidate capable of independent work in a collaborative, fast-paced environment.

Responsibilities:

• Develop Raw Materials testing program and perform/oversee testing of incoming raw materials for quality, identity, purity, and contamination, ensuring compliance with GMP standards.
• Develop, revise, and implement SOPs for raw material testing, ensuring alignment with regulatory requirements.
• Participate in qualification and validation activities for new raw materials, including method development and optimization.
• Collaborate with the Material and Supply Chain and Quality Assurance Department to manage the receipt, inspection, and release of raw materials.
• Coordinate with third-party laboratories for outsourced raw material testing and ensure timely reporting of results.
• Maintain detailed records of raw material testing and work closely with the QC and MFG departments to support timely material release.
• Investigate and resolve Out of Specification (OOS) results and deviations related to raw materials.
• Train and mentor other QC staff on raw material testing procedures as required.
• Support continuous improvement initiatives to streamline raw material testing processes and ensure compliance with regulatory guidelines.
• Collaborate with other departments to troubleshoot and resolve issues related to raw materials or testing procedures.

Requirements:

• Bachelor’s degree in a relevant scientific discipline (e.g., Chemistry, Biology, Biochemistry) is required.
• 5+ years of experience in a GMP/GLP Quality Control laboratory, with a focus on raw material testing.
• Experience with analytical techniques relevant to raw material testing.
• Strong knowledge of GMP compliance and regulatory requirements related to raw materials.
• Ability to work independently as well as in a team-oriented environment with effective communication and time management skills.
• Proficiency with MS Office, QT9, and other electronic systems for data management and reporting.
• Strong attention to detail with problem-solving abilities.

Work Environment / Physical Demands:

• Must be able to sit and stand for extended periods.
• Must be able to lift / carry reports and materials up to 40 pounds, move about the office.
• Able to fully gown and work in an ISO 7 manufacturing area.

PI250860931