Precision Therapeutics, Inc. (Precision), a life-science company located in Pittsburgh, PA, is committed to improving outcomes of cancer patients. Known for their expertise in the science of individualizing cancer therapy through the use of a proprietary and unique live-tissue platform, Precision develops novel markers to help guide treatment decisions based on the biological processes of each individuals cancer.
The purpose of the QC - Quality Control Specialist is to provide, implement, sustain, and improve inspection, validation, and other quality-related processes.
Duties & Responsibilities:
Duties will include but not be limited to:
- In-process inspection
- Validation and release testing
- Incoming inspections and specifications
- Process standardization
- Ensure regulatory requirements are met
- Process improvement
- Assist with internal and external audits
- Proficiency testing
- Other dues as assigned
- Bachelors degree in Biology or related field or
- Experienced and Certified Histotechnologist
- 2+ years working in a CLIA or FDA regulated environment
- Writing and adherence to Standard Operating Procedures
- Aseptic laboratory technique
- Experience with automated systems for cellular imaging.
- Cell culture maintenance
- Cut tissue blocks, both paraffin and frozen.
- Stain and validate new custom IHC markers
- Perform ISH and FISH procedures
- Maintenance and QC of instrumentation and equipment
- Clinical laboratory process validation (DQ-IQ-PQ-OQ)
- Demonstrates knowledge of and can perform IHC testing
- ASCP certifications (QIHC, HTL, HT) preferred
- Knowledge of Lean, Six Sigma, or other continuous improvement methodologies
- Statistical Process Control
- Proficiency testing
- Commitment to implementing continuous process improvement programs
- Highly Motivated and quick learner
- Able to work independently or in small teams
- Problem-solver who makes sound decisions
- Highly organized and detail oriented
- Ability to inspire and motivate others to perform well
- Well developed and effective communication skills, verbal and written
- Proficient with Microsoft Office Tools - Excel, Word, Project.
StartUpHire - 2 years ago
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