What are the responsibilities and job description for the Quality Control Specialist position at X4 Life Sciences?
Position: Quality Control Specialist – MedTech
Location: North New Jersey (Onsite)
Exciting opportunity to join a cutting-edge MedTech company focused on cellular therapies. We're looking for a Quality Control Specialist who is dedicated to ensuring the highest product quality standards in a fast-paced medical device manufacturing environment.
Key Responsibilities:
- Inspect and approve incoming materials by verifying their specifications through visual checks and measurements, rejecting materials that don’t meet the criteria.
- Supervise the production process to ensure product specifications are adhered to and provide feedback to improve any areas of non-compliance.
- Maintain detailed records of inspection results, documenting all findings and actions taken.
- Conduct a variety of QC tests, including LAL (Limulus Amebocyte Lysate) tests, for both manufacturing and validation processes.
- Perform final product inspections to ensure all specifications are met and document outcomes.
- Verify and approve sterilization certificates for products.
- Ensure measuring equipment is calibrated and functioning according to maintenance schedules.
- Oversee the cleanliness and functionality of the laboratory, clean room, and QC testing areas.
- Conduct routine audits, including low-dose testing, and support the validation of testing methods.
- Support additional tasks as needed to maintain compliance with company and regulatory standards.
Qualifications:
- 3 years of experience in quality inspection or production within the medical device industry.
- Strong understanding of laboratory equipment and quality control processes.
- Ability to lift up to 50 pounds when required.
- Bachelor’s degree in a related field.
