Quality Control Associate - Medix™ : Job Details

Essential Functions and Responsibilities

• Ensure all procedures and processes comply with internal quality standards and external regulations for pre-clinical, clinical, and commercial manufacturing.
• Read, comprehend, and adhere to cGMP and cGTP documentation for Quality System Functions (SOPs, WIs, etc.).
• Maintain cGMP and cGTP compliance in all areas of pre-clinical, clinical, and commercial manufacturing.
• Release raw materials in the ERP system and record manually.
• Perform accessioning of incoming apheresis.
• Review batch records and manage material disposition for finished products to clients.
• Provide information regarding Out of Specification results and deviations to investigators.
• Conduct line clearance before the start of manufacturing operations.
• Support tech transfer activities.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree or higher in a scientific field.
• 0-2 years of experience in a biologics or biotechnology company.
• Familiarity with the aseptic manufacturing process for biologics is preferred.
• Knowledge of GMP and TCTP regulations.
• Experience reviewing GMP/GCTP-related documents (validation/qualification reports, SOPs, etc.).

Competencies/Candidate Profile

• Proficient in relevant computer software (Microsoft Office, Outlook).
• Strong attention to detail and organizational skills.
• Excellent analytical and problem-solving abilities.
• Effective written and oral communication skills.
• Capable of multi-tasking and adapting to change.
• Flexible and able to adjust to the company's growth and evolving responsibilities.
• Able to work both independently and as part of a team.