Quality Assurance Operations Specialist II

Summary

Cartesian Therapeutics a fully integrated clinical stage biopharmaceutical company pioneering RNA cell therapy is currently seeking a Quality Assurance Operations Specialist II with experience in biopharmaceutical quality assurance.

The ideal candidate will be a highly motivated professional who can support Cartesians Quality Assurance operations. The QA Operations Specialist II will co-represent quality for GxP operations at Cartesian a fast-paced cell therapy environment. The candidate should embrace a collaborative work environment and be able to execute projects with support from leaders. This position is ideal for candidates with experience in cGMP environments with knowledge of ICH guidelines and FDA compliance for late stage Biotech preferably clinical cell therapy products.

Principal Duties/Responsibilities:

• Execute the daily operations of Quality Assurance including review of QC manufacturing and facility records
• perform quality on the floor using real-time oversight.
• Foster a culture of teamwork and alignment.
• Perform lot release processes with Quality Control Manufacturing and external partners.
• Provide support during regulatory audits and 3rd party inspections.
• Author review and/or approve standard operating procedures (SOPs)/policies and technical reports with general guidance.
• Participate in investigations (deviations out-of-specification (OOS) results customer complaints) performing assessments and authoring protocols/reports.
• Contribute to qualification and validation activities for Manufacturing and Quality Control in collaboration with Manufacturing Quality Control and Validation personnel.
• Review and approve Validation documentation.
• Co-author trending reports and quality reviews for senior management on key performance indicators within Cartesians QMS.
• Independently identify and resolve or appropriately escalate problems through quality risk management and sound decision-making skills.
• Communicate professionally both verbally and in writing and effectively represent the function. Demonstrate strong listening skills interpersonal savvy and peer relations.
• Effectively present complex data and strategies to groups.

Qualifications:

• 2 years of related experience with a Bachelors degree; or a Masters degree
• Knowledge of current Good Manufacturing Practices (cGMP) and other applicable regulations and standards.
• Experience participating in internal and external audits and inspections.
• leadership communication interpersonal and problem-solving skills.
• Ability to work as part of a cross-functional team in small biotech environment.
• Experience in cell therapy quality operations is highly preferred.
• Experience in late stage clinical/commercial preferred.
• Experience with health authority inspections preferred.

Work Environment:

We offer a dynamic intellectual environment with amenities including:

• High tech office setting
• Free snacks and beverages
• Social game and relaxation areas

Depending on expertise this position may require occasional hands-on work (e.g. to train others) in a GMP cleanroom these instances employees work in an environment in which safety environmental and health concerns require strict adherence to Cartesians policies rules and regulations. This includes the use of appropriate safety and personal protective equipment.

At Cartesian Therapeutics we are committed to transparency and equity in our compensation practices. The salary range for this position is $75000 to $93000 per year. Please note that the final salary will be determined based on several factors including but not limited to years of experience industry experience education and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process.

Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race color age religion sex sexual orientation gender identity national origin ancestry disability marital status genetic information military status or any other characteristic protected under applicable law.

Required Experience:

IC