QC - Quality Control Specialist - Biomarkers Precision Therapeutics -
Pittsburgh, PA
The Opportunity:
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
Qualifications:
Education
Bachelors degree in Biology or related field or
Experienced and Certified Histotechnologist
Experience:
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
Required Skills:
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.
