What are the responsibilities and job description for the Senior Quality Assurance Operations Specialist position at Cartesian Therapeutics?
Summary
Cartesian Therapeutics, a fully integrated, clinical stage biopharmaceutical company pioneering RNA cell therapy, is currently seeking a Quality Assurance Senior Specialist with experience in biopharmaceutical quality assurance.
The ideal candidate will be a highly motivated professional who can support Cartesian's Quality Assurance operations. The Senior Specialist of QA will oversee 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.
- Lead investigations (deviations, out-of-specification (OOS) results, customer complaints), performing assessments and authoring protocols / reports.
- Oversee qualification and validation activities for Manufacturing and Quality Control in collaboration with Manufacturing, Quality Control, and Validation personnel.
- Review and approve Validation documentation.
- Author / co-author trending reports and quality reviews for senior management on key performance indicators within Cartesian's QMS.
- Independently identify and resolve 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 :
Work Environment :
We offer a dynamic, intellectual environment with amenities including :
Depending on expertise this position may require occasional hands-on work (e.g., to train others) in an R&D laboratory setting. In these instances, employees work in an environment in which safety, environmental, and health concerns require strict adherence to Cartesian's 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 $93,000 to $116,000 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.
Salary : $93,000 - $116,000
