Advanced Quality Technician
Job Details
Experienced
Devens - Devens, MA
Full Time
High School
None
Day
Quality & Regulatory
Description

By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Position Summary:

Advanced Quality Technician reports to the Quality Control Manager and is responsible for in-process and final QC testing of Bionostics products.  In addition, Advanced Quality Technician participates in instrument validations, performs lab maintenance activities, initiates collaborations, monitors laboratory and process inventories, conducts device history record review, and creates certificates of analysis for commercial products.

Key Responsibilities:

  • Understands and adheres to all quality technician job requirements
  • Follows work instructions carefully and demonstrates good documentation practices
  • Documents results, processes testing, and refers to past batch records when needed
  • Compiles, analyzes and reports on data conformity
  • Demonstrates flexibility to work on multiple tasks with increased effectiveness
  • Work may change from day-to-day within reasonable and expected boundaries
  • Oversees facility monitoring tasks
  • Participates in proficiency rotations through six key areas of responsibility in the lab
  • Prepares instrument validation protocols and writes instrument validation reports
  • Initiates and participates in updating and maintaining controlled documentation through the current
  • electronic record keeping system
  • Assists in complaint investigations as needed
  • Takes on special assignments assisting with test method development and protocol writing as needed
  • Works independently with minimal supervision on moderately complex tasks a majority of the time
  • Prioritizes own work to meet deadlines and complete multiple tasks effectively and efficiently
  • Supports and helps others on the team, participates in training of new employees
  • Performs laboratory maintenance tasks
  • Consistently follows good laboratory practices and site-specific lab protocols regarding
  • Utilizes site applicable databases effectively, including controlled documentation systems and data
  • management software
  • Participates in engineering change orders and non-conforming material report
  • Initiates or participates in QC related ECO collaborations such as SOP generation and revision
  • Understands the basic ISO protocols and other applicable standards
  • Participates in continuous process improvements efforts
  • Assists in CAPA investigations and closures
  • Communicates effectively across groups and sites
Qualifications

Education and Experience:

  • High School degree with 5+ years of relevant technical experience
  • Science or quality related Associate’s degree with 3+ years of experience
  • Science or quality related Bachelor’s degree; with a minimum of 1+ years of experience
  • Availability for overtime and weekend work is required
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