Manufacturing Associate

Company: Kelly
Location: Boulder
Posted on: April 10, 2021

Job Description:

Manufacturing Associate Temp to Hire 8 AM-5 PM $20-$25.00 per hour 1- year of GMP Experience, Aseptic Technique, familiar with basic laboratory equipment and aliquoting samples. Overview The Manufacturing Associate is primarily responsible for performing manufacturing activities in our specialty IVD manufacturing lab. The majority of day-to-day activities will be focused on manufacturing, inspecting, labeling, and packaging of our product. The Manufacturing Associate is responsible for maintaining manufacturing space cleanliness. The operations include handling cryogenic materials so attention to safety is critical. This role will also provide essential feedback on new process development and assist in performing system RESPONSIBILITIES:

• Manufacture product as specified in controlled manufacturing procedures, and in compliance with regulations and guidelines
• Cleaning, sterilizing and preparing laboratory on a daily basis/maintain the manufacturing area per company specifications
• Labeling, organizing and maintaining consumables inventory
• Generation of bulk material and aliquoting of non-hazardous liquid reagents
• Operate manufacturing, manufacturing-support and lab equipment as trained
• Clean, prepare and assemble equipment for processing operations
• Movement of consumables and finished product into appropriate locations
• Adhere to Company policies and safety guidelines
• Documentation
• Assist in the preparation of reports and other documentation as applicable to the scope of manufacturing
• Accurately complete documentation of manufacturing batch records, using Good Documentation Practices
  • Initiate deviations, Risk Assessments and NCRs
  • Accurately update applicable WO data into an ERP system
  • Responsible for ensuring inventory supply levels are maintained and puts POs in as necessary
  • Ensures equipment calibration and preventative maintenance services are completed and documented in compliance with quality system
  • Additional responsibilities as assigned
  • Review, understand, and comply with Company HIPAA Security policies and procedures EXPERIENCE: 1+ years' experience in an operations, manufacturing, or similar environment preferred Good Manufacturing Practices (GMP) Experience at an FDA regulated biotech, pharmaceutical, or medical device manufacturer is a plus Previous experience with manufacturing of class 2 and preferably class 3 Medical Device also is a plus Experience with aseptic or molecular biology technique is a plus
    
    EDUCATION: High School Diploma or A.S. degree in biological or physical science. Degree requirement may be waived with relevant experience in an FDA regulated, controlled production environment, including Manufacturing, Quality Control, Quality Assurance, and/or Materials Management Basic understanding of cGMP requirements per 21CFR820 preferred but not required Basic understanding of ISO 13485 preferred but not required Technical accuracy and ability to perform mathematical calculations Why Kelly -- ? Kelly-- Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly -- At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Keywords: Kelly, Boulder , Manufacturing Associate, Other , Boulder, Colorado