Bellicum Pharmaceuticals, located in the Houston Medical Center, is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are dedicated to creating an exceptional work environment where we develop products that can make a difference in the quality of life for patients.
Due to our continued growth, an excellent opportunity is available for a Quality Assurance Specialist ll –Operations Line Auditor. This role is responsible for representing Quality on the cellular manufacturing floor and to provide oversight to Manufacturing during the execution of their processes and procedures.
Specific Job Duties
• Inspect manufacturing floor and provide real time review of in-process test data, calculations, batch records, supporting documents, materials and aseptic processing technique in order to ensure adherence to cGMP’s on the production floor at all times.
• Guide and advise operations associates as necessary on cGMP’s and Good Documentation Practice.
• Proactively identify compliance issues and support the manufacturing operations in detecting and solving compliance errors in real time.
• Responsible for ensuring products are produced in a manner that meets all cGMP and company procedures.
• Supports nonconformance investigations, reviews of nonconformance investigations, and follow up on corrective action plans to prevent issue reoccurrence.
• Support the facility during internal and external audits and inspections.
• Perform inspection and release of leukapheresis starting material to manufacturing team for processing.
• Quality Assurance oversight within GMP material receiving area, raw material inspection and supports release of raw materials for manufacturing according to disposition timelines.
• Must have a minimum of 5 years’ Quality Assurance experience in Biotechnology
• cGMP experience in both Quality and Manufacturing required
• Experience in 21 CFR 210/211 and 810.
• Proven experience within a clean room environment
• Experienced in aseptic techniques
• Minimum Bachelor’s Degree in Sciences or related discipline.
• Must have proven time management and project development skills.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills, is required.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing a number of projects simultaneously.
We offer a competitive Total Rewards program including stock options and employer supported benefit premiums. We thank you for your interest in Bellicum and your submission. Please be advised that only those candidates selected to move forward will be contacted.