What are the responsibilities and job description for the Quality Assurance Specialist position at Akron Bio?
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
The Quality Assurance Floor Support Specialist works as a member of the QA team and reports to the QA Quality Manager. The primary responsibility is providing quality oversight during GMP or other critical activities Responsibilities include providing QA oversight to GMP operations and critical operations, as well as performing inspections, supporting sample management, environmental monitoring, batch record and logbook review, support for gowning and aseptic technique for as well as. QA Floor Support Specialist oversees GMP operations on the shop floor to achieve site goals through effective quality oversight.
Responsibilities
- Ensures regular presence on the shop floor during productions and critical activities. .
- Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
- Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
- Ensure processes and testing are completed per procedures, materials are released and appropriate for use
- Support label review, and reconciliation
- Provide troubleshooting/ triage support for deviations as they occur in real time. Communicates with QA Manager on quality and operational issues.
- Advise Operations and support personnel on quality matters, while driving the site Quality culture.
- Provide support to training activities such as gowning, EM testing, aseptic technique as required.
- Reviews and approves GMP documentation in support of daily operations such as: batch record logs, paper logbooks, cleaning, and procedures versus performance.
- Provide QA systems support to reconcile issues in systems; such as, inventory control systems (SAP), laboratory LIMS system, and TrackWise
- Participate in self-led inspections and provide support during internal / external regulatory inspections.
- Update and support update of SOPs, forms and batch records and protocols
Requirements
- Minimum of 3 years relevant industry experience, pharmaceutical, biotech, devices, etc
- Degree in science or related field is preferred
- Fluent in English with excellent verbal and written communication skills are required
- Quality Assurance experience including sterility assurance and aseptic processing
- Direct experience supporting the manufacturing, testing, disposition, and distribution of cGMP sterile products in the Manufacturing or Quality organizations
- Working knowledge of standards quality control assays and analytical methods
- Knowledge of ANMAT, FDA, EMA, GMP, ISO regulations and standards is preferred
- Demonstrated capability with trouble shooting, and problem-solving
- Must be highly motivated and able to work independently and also collaboratively with cross functional groups
EOE/DFW
