Compensation :
- Fully remote role!
- $48-$56 / hr - Exact compensation may vary based on several factors, including skills, experience, and education.
- Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching.
Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law.
Minimum Qualifications :
- Bachelor Graduate in Biology, option Biomedical Research
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Excellent computer proficiency e.g MS Office, TrackWise, Minitab
- Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
- Ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Essential Job Duties and Responsibilities
The External Quality Specialist will provide QA support for TAR-200 (including UPC) and TAR-210 projects, ensuring adherence to quality assurance processes and compliance with all company policies and procedures.
Responsible for product release, ensuring products meet cGMP, customer specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes.
Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety.
Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required. Responsible for continuous improvement and risk management activities of EM.
Support, review / pre-review, and / or approve the following
- Batch record review
- Quarantine shipment (Q-ship) activities
- Release for Further Processing (RFFP) activities
- EM Quality Events
- EM CAPAs
- EM Change Controls
- EM Planned Deviations
- EM Product Quality Complaints
- EM Protocols
- EM Risk Assessments
- EM Electronic Batch Record (eBR) changes
- EM Manufacturing Process Instruction (MPI) changes
- EM equipment specific Master Validation Plan (MVP) changes
- Sterilization-specific documentation
- New equipment qualification documentation
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