What are the responsibilities and job description for the QC Analyst 2 position at bioMérieux?
Position Summary:
Executes routine biochemistry tests per standard operating procedures. Tests may be raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory.
Primary Responsibilities:
Education, Skills, & Experience:
Executes routine biochemistry tests per standard operating procedures. Tests may be raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory.
Primary Responsibilities:
- Performs routine testing of samples submitted to the laboratory.
- Documents all test results in compliance with procedures and GDP requirements.
- Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
- Maintains laboratory equipment in compliance with procedures and GLP requirements.
- Enters data into LIMS system. Assists with LIMS data entry to support LIMS maintenance and validation activities.
- Maintains personal training file. Responsible for training of other analysts as directed by management.
- Assists with scheduling of raw material, intermediates, environmental monitoring samples, and finished goods submitted to the laboratory as directed by management.
- Assists in the ordering and stocking of laboratory supplies; may have responsibility for inventory management.
- Provides input to laboratory investigations and documents invalid test results in compliance with procedures. Assists with nonconformance and CAPA investigations in compliance with procedures.
- Assists with revisions to standard operating procedures.
- Perform any additional job related duties as requested
Education, Skills, & Experience:
- BS with 2 years of relevant experience required.
- In lieu of a Bachelor’s Degree, a high school diploma/GED with a minimum of 6 years of progressively responsible experience OR an Associate’s Degree with a minimum of 4 years of progressively responsible experience working in a regulated, GMP environment.
- Technical and scientific knowledge working with relevant 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.).
- Experience with biochemical testing, knowledge of USP and EP/BP method/validation regulations.
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