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Description

Position Summary:

The normal working hours for this position are night shift: 7:00pm - 7:30am working a 2-2-3 rotation schedule. 

The QC Biochemistry Analyst 1 role is responsible for routine Biochemistry testing. The responsibilities of this position include Investigational writing & testing of raw materials, intermediates, special test requests, stability, and finished product samples per standard operating procedure. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 1 will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC. 

Primary Responsibilities:

• Quality
  • Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
  • Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
  • Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.
  • Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
  • Executes laboratory investigations as assigned by management in compliance with procedures.
  • Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
• Documentation/Training
  • Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
  • Ensures personal training is maintained to current department processes and procedures.
• Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
• Continuous Improvement
  
  • Participate in continuous improvement activities.
  • 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.
• Performs additional job-related duties as assigned by management.

Education, Skills, & Experience:

• Bachelor's degree with 0 years of experience required.
  • In lieu of a Bachelor’s Degree, a high school diploma/GED with 4+ years of experience in a regulated laboratory environment OR an Associate’s Degree with 2+ years of experience working in a regulated laboratory environment, also accepted 
  • Lab experience in Biochemistry or Chemistry highly desired
  • BS degree in Biochemistry, Chemistry, or Biology is preferred
• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP) preferred.
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills preferred.
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations preferred.
• Experience handling chemicals in a lab environment (academic or professional) is preferred

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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).