Quality Assurance Specialist III
Job Title: QA Specialist III
Location: Louisville, KY
Reports to: Quality Assurance Manager
The Quality Specialist III is responsible to provide Quality Assurance support for GMP Manufacturing. Responsibilities include providing oversight of manufacturing including observing critical processes, executed GMP documentation review, oversight of validation of GMP equipment, preventative maintenance, and calibration, and supporting other QA functions as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
Principal Duties and Responsibilities:
- Provides QA support to and quality oversight of GMP operations for the manufacture of drug product used in clinical trials and for commercial use.
- Conducts review of executed batch record and ancillary documentation for accuracy and completeness, for compliance with approved procedures. Communicates and resolves discrepancies with manufacturing operators or supervisors
- Completion and approval of Final Product Certificates of Analysis and Final Product release
- Releases final product for clinical or commercial use
- Performs QA review and approval of Master Batch Records, Protocols, Reports, and SOPs
- QA support for validation function, reviewing and approving applicable procedures, policies, plans, protocols & reports.
- Performs Quality on the Floor activities including line clearance/room release, receipt of patient material, and drug pack-out, as well as quality walk-throughs of the production, testing and warehouse locations.
- Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs) with approval authority as designated by QA Management.
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Review and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
- Support the review and approval of incoming raw materials
- Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
- Qualify suppliers and service providers to meet Talaris requirements, including independently conducting audits
- Support the review and approval of incoming raw materials
- Quality oversight of preventive maintenance and calibration programs
- Write, revise, and approve GMP documentation as necessary
- Lead site and corporate quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
- Work cross-functionally with Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner
- Conduct audits of manufacturing and support areas for adherence to internal procedures and industry best practices
- Support regulatory (i.e. FDA, EMA) audits/inspections
- Performs other duties as assigned
Minimum Education, Training, and Experience Required:
- Bachelor’s degree in a Life Sciences discipline; Master’s degree is preferred
- 7+ years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
- 4+ years’ experience in Quality Assurance/Quality Control function
- Working knowledge of Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines. . Familiarity with 21 CFR Part 1271 and ATMP regulations a plus.
- Knowledgeable of GMP manufacturing processes, particularly for biological or cell and gene therapy products.
- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Familiarity with use of methodologies like six sigma and Kaizen to improve process/product quality is a plus.
- Detail oriented team player with effective planning, organization and execution skills.
- Excellent verbal and written communication skills.
- Strong computer skills with Word and Excel; experience with E-Systems is preferred.
- Ability to work effectively at a fast pace with cross functional departments.
- Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift 15 pounds at times.
- Must be able to access and navigate each department at the organization’s facilities.
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off 25 days
- Stock Options
Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant without rejecting their donated organ. We have followed these patients for an average of over six years since their transplant, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. We are currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, and in the second half of 2021 we will be initiating FREEDOM-2, in which we will evaluate the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, as well as FREEDOM-3 in which we will evaluate the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 100 employees and have a corporate office in Boston, MA in addition to our cell processing facility in Louisville, KY.