Position Summary

“The QC Biochemistry Analyst 2 role is responsible for routine Biochemistry testing.
The responsibilities of this position include:
• Testing of raw materials, intermediates, special test requests, and finished product samples per standard operating procedures.• Investigational writing of INVALID reports.
• Provide input and support for Out of Specification reports.
• Serve as a certified trainer for laboratory testing as applicable.”

Primary Duties

• Participates as a trainer for Quality Control testing and instrument maintenance.
• Troubleshoots simple to moderate Biochemistry laboratory equipment related issues.
• 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.
• 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.
• 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.
• Assists with revisions to QC department standard operating procedures (SOPs) as directed by management.
• Ensures personal training is maintained to current department processes and procedures.
• Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
• Participate in improvement initiatives as directed by management.
• Work with other departments and assist with executing validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures including revalidation as scheduled or required to maintain systems in a validated state.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

Required Education, Training, and Experience

• High School Diploma, GED or equivalent
• 4+ years of experience working in a regulated Biochemistry or Chemistry laboratory (FDA, ISO, USDA, etc.) with GxP testing

Preferred Education, Training, and Experience

• Bachelors degree highly preferred in Chemistry, Biochemistry, or Biomedical
• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
• Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
• Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.

Working Conditions and Physical Requirements

• Ability to remain in stationary position, either sitting or standing, for prolonged periods.
• Ability to wear PPE correctly most of the day.
• No ability required for ascending/descending stairs, ladders, ramps, etc.
• No ability required to operate heavy machinery.
• No requirement to adjust or move objects up to 50 pounds in all directions.
• Domestic travel required: 0%
• International travel required: 0%

Key Skills (from KSAs)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Written Communications – including the ability to communicate technical data in written form
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel – Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
• Excellent and effective verbal and written communication skills.
• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.