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:
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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.
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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.
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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:
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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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