Are you looking to play a pivotal role in supporting the development and operations of a commercial-scale cGMP cell therapy manufacturing and laboratory facility? This exciting position offers the opportunity to provide quality oversight, collaborate with cross-functional teams, and ensure systems and equipment meet the highest quality standards throughout their lifecycle.
Shift:
Monday to Friday, 3:00 PM - 11:30 PM
Key Responsibilities:
Identify risks and develop mitigation strategies in collaboration with teams across Manufacturing, Quality Control, IT, Supply Chain, Engineering, and Validation.
Support quality improvement efforts for cGMP facilities and remote laboratories.
Develop and maintain documentation, including quality manuals, SOPs, and work instructions.
Ensure adherence to Good Manufacturing Practices (GMP).
Represent Quality on cross-functional teams to address quality issues and implement system improvements.
Provide technical guidance for quality engineering activities, including root cause analysis, corrective actions, and process changes.
Oversee lifecycle verification programs for manufacturing and laboratory systems.
Qualifications:
Bachelor's degree in a scientific or engineering discipline.
3+ years of experience in the biopharmaceutical industry in a technical or support role.
2+ years of experience in GxP system implementation and validation.
Experience in a Quality role is highly desirable.
Strong knowledge of inspection/testing processes and lifecycle verification for single-use systems, lab systems, and software in a cGMP environment.
Proven experience developing policies and procedures for new cGMP facilities.
Exceptional communication, collaboration, and problem-solving skills.
Proficiency in Microsoft Office Suite.
Physical Demands:
Ability to stand and walk for 90% of a 10-hour shift, with some crouching, bending, and climbing.
Must be able to lift and carry objects weighing up to 45 pounds.
Comfortable wearing cleanroom attire and PPE, including respirators.
Work Environment:
Split between office and manufacturing lab settings.
Exposure to biohazards, chemicals, and equipment hazards in a cleanroom environment.