QC Analyst - Night Shift

Position Summary – QC Analyst 2
The normal working hours for this role is NIGHT SHIFT 7:00pm - 7:30am working a 2-2-3 rotation schedule.
Generic Summary

Quality Control is responsible for testing and confirming product safety and efficacy through laboratory. Execute, raw material, intermediate products, final product and stability testing as defined to ensure product meets the established acceptance criteria prior to the product's release for commercial sale.

“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.

• 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.

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

• Bachelor's 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.

• Ability to remain in stationary position, either sitting or…