What are the responsibilities and job description for the Quality Assurance Operations Specialist position at Tap Growth ai?
🌟 We're Hiring: Quality Assurance Operations Specialist! 🌟
We are seeking a detail-oriented and analytical Quality Assurance Operations Specialist to ensure our products and processes meet the highest standards of quality. The ideal candidate will have experience in quality control methodologies, process improvement, and operational excellence to maintain compliance and drive continuous improvement initiatives.
📍 Location: Philadelphia, PA
What You'll Do
We are seeking a detail-oriented and analytical Quality Assurance Operations Specialist to ensure our products and processes meet the highest standards of quality. The ideal candidate will have experience in quality control methodologies, process improvement, and operational excellence to maintain compliance and drive continuous improvement initiatives.
📍 Location: Philadelphia, PA
What You'll Do
- Perform QA Operations activities that include review of manufacturing batch records and labeling/packaging operations to ensure timely release of cell therapy products.
- Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition
- Perform real-time, on-the-floor support for manufacturing production activities to ensure compliance with GMP and GDP quality initiatives, escalating issues as required.
- Track and communicate standard work completion and hurdles.
- Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
- Maintain a collaborative and professional relationship with CMOs.
- Release of raw materials and inventory.
- Prepare and organize release documentation for approvals.
- Support internal audits and regulatory inspections.
- BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college.
- At least 2 years demonstrating proficient GMP QA/QC experience.
- Experience with use of an electronic QMS (i.e. MasterControl, Veeva)
- Familiarity with Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
- Knowledge of GMP, Good Documentation Practices (GDP) and FDA quality system
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to perform cleanroom gowning and pass gowning qualification.
- Must meet requirements for and be able to wear a half-face respirator.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
- Mental Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
