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.

Medix is acting as an Employment Agency in relation to this vacancy.

QC Associate