Quality Operations Supervisor
3 days ago
We are seeking a highly skilled Quality Operations Supervisor to join our team at Iovance Biotherapeutics Inc. This is a unique opportunity to work in a fast-paced environment and contribute to the success of our company.
Key Responsibilities:
- Supervise and develop direct reports, providing guidance and support to ensure the highest quality standards are met.
- Perform real-time support for escalations, ensuring compliance with GMP and GDP quality initiatives.
- Schedule and coordinate daily activities, ensuring conformance to the daily schedule.
- Apply quality compliance theories and principles to address issues of moderate scope, providing guidance on controlled documents and suggesting process improvements.
- Ensure compliance to cGMPs and facility procedures, interfacing with functional groups to determine events and escalate if necessary.
- Review batch records and related production documentation, ensuring resolution of all identified issues prior to product disposition.
- Support the release of drug product and materials during the shift, issuing lot numbers and supporting documentation as needed.
- Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
- Review Quality System records for compliance.
Requirements:
- Minimum B.S. in biology, biochemistry, bioengineering, or related technical field, or equivalent industry and technical experience.
- Minimum of 5 years of experience in biopharmaceutical-based GMP aseptic manufacturing, with a minimum of 2 years in a Lead/Leadership/Supervisory Role.
- Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals.
- Excellent oral and written communication skills, with the ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
- Ability to work in a fast-paced environment and changing priorities, with a strong desire to learn and take ownership and accountability.
Work Environment:
This position will work in both an office and a manufacturing setting, with potential exposure to various chemicals/biochemicals, including latex and bleach. The individual must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), and meet requirements for and be able to wear a half-face respirator.
Physical Demands:
- Must be able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing up to 45 pounds.
Mental Demands:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
- Ability to handle work-related stress, handle multiple priorities simultaneously, and meet deadlines.
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