Quality Assurance Engineering Specialist
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.