Quality Control Technician Precision Therapeutics

Precision Therapeutics, Inc. (Precision), a life-science company located in Pittsburgh, PA, is committed to improving outcomes of cancer patients. As leaders 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.

Precision is looking for a Quality Control (QC) Manager reporting to Director of Quality Systems and Process Improvement.


The Quality Control Manager will be responsible for leading team of Quality Technicians and Quality Specialists in execution of quality control tasks associated with ensuring that the Precision Therapeutics Clinical Operations Group consistently provides accurate and timely information to the physician.



Duties & Responsibilities:

Duties Include But Not Limited To:

Ongoing Monitoring of each testing process used in at PTI Clinical Laboratories in Order to identify errors or potential problems that could result in errors;
Identifying root cause and taking corrective action;
Evaluating the corrective actions taken, to make sure that they are robust and effective and will prevent recurrence.
Validation of Laboratory Tests and Materials to Satisfy Various Regulatory Standards, ex: CLIA, NYSDOH, FDA Etc.
Providing Leadership and Daily Direction to QC Personnel
Support the Creation, Standardization and Maintenance of Standard Operating Procedures (SOP) to ensure Quality Performance of the Laboratory as well as ensuring all Regulatory Requirements are met.
Support and Lead Process Improvements in the Clinical Laboratory.
Support and Lead Execute Internal and External Audits to Ensure Compliance with Various Regulatory Standards, Ex: CLIA, NYSDOH, FDA Etc. And PTIs Quality and Safety Management System

Provide input to the quality manual, internal and external quality audits, trending/metrics, statistical control and methods applications, risk management, process mapping/analysis, and writing and reviewing QC and other SOPs.
Reports periodically to top management the quality compliance status via management review system
Manages compliance activities, NCR, CAPA, and customer complaints functions.
Keeps up with FDA IVD Medical Devices quality regulations and developments.
Manages the QC personnel group and personal development.



This position is best suited to someone desiring to work in a proactive team environment that places strong emphasis on providing accurate and timely quality compliance information to management.



Qualifications:



Education:
BS or MS degree with a major in a natural or engineering science preferred.
Preferred individuals with appropriate ASQ Certifications or other quality systems training or degrees
FDA or ISO 13485 IVD and Medical Devices Quality Systems compliance training, workshops or degrees



Experience:
3 to 5 years minimum experience in FDA or CLIA clinical laboratory environment.
Prefer experience in the In Vitro Diagnostics Lab, Medical Device or Pharmaceutical business.
2 to 3 years minimum experience as a quality engineer/ manager and/or supervisor
Experience in auditing, laboratory process validation, risk management, FDA QSR, GLP, CLIA, and New York state inspections, document control, process mapping, six sigma/quality tools, ISO 13485, material stability, CAPA.
Experience in Lab Information System and Computer software for quality systems



Required Skills:
Preferred knowledge of clinical laboratory standards and regulatory requirements (accreditation, governmental regulation)
Technical knowledge of anatomic pathology, IHC, gene expression, gene mutation, and histology testing methods, instrumentation and procedures
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
Understanding of Lean Six Sigma (prefer Certified Green or Black Belt)
Basic Understanding of Statistical Analysis and tools.

Location:	2516 Jane Street Pittsburgh, PA 15203 United States