QC Analyst 2 - Night Shift

Night shift position with a 2-2-3 rotation schedule (7:00 PM – 7:30 AM).

About the role

As a QC Biochemistry Analyst 2, you will perform routine Biochemistry testing of raw materials, intermediates, special test requests, and finished product samples in compliance with standard operating procedures. You will also contribute to laboratory investigations, document invalid test results, and serve as a certified trainer for laboratory testing and instrument maintenance.

Responsibilities

• Perform testing of raw materials, intermediates, and finished product samples per SOPs.
• Write and investigate invalid test reports; provide input and support for Out of Specification reports.
• Serve as a certified trainer for Quality Control testing and instrument maintenance.
• Troubleshoot simple to moderate Biochemistry laboratory equipment issues.
• Ensure all testing documentation is completed accurately, thoroughly, and timely in compliance with GDP requirements.
• Document test results and ensure review of laboratory testing is completed per SOPs.
• Maintain compliance with SOPs, GLP, GMP, and HSE requirements.
• Prepare for and support regulatory, customer, and internal audits of Biochemistry laboratory areas.
• Execute laboratory investigations as assigned by management.
• Enter data into the Laboratory Information Management System (LIMS) and applicable paper-based data sheets.
• Assist with LIMS maintenance, validation activities, and revisions to QC department SOPs.
• Maintain personal training on current department processes and procedures.
• Utilize Personal Protective Equipment (PPE) as required for laboratory duties.
• Participate in improvement initiatives and assist with executing validation protocols for Biochemistry laboratory equipment, software, and procedures.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Requirements

• 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.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or Biomedical fields highly preferred.
• Technical and scientific knowledge of relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
• Experience with software tools for data entry and analysis (LIMS) and advanced technical writing skills.
• Experience participating in the management of regulatory audits (e.g., FDA, MDSAP, ISO, OSHA, EPA).
• Knowledge of USP and EP/BP method/validation regulations.
• Ability to remain in a stationary position (sitting or standing) for prolonged periods and wear PPE correctly most of the day.

Skills

• Strong written and verbal communication skills, including the ability to communicate technical data effectively.
• Proficient in MS Office tools (Outlook, Teams, Word, Excel) at an intermediate level.
• Proven ability to problem-solve and troubleshoot with minimal supervision.
• Ability to read, understand, and execute standard operating procedures.
• Upholds core ethical principles and values.

Pay

Estimated salary range for this role in North Carolina is $24 – $36.30/hour. Eligible for a variable annual bonus based on company, team, and individual performance.

Benefits

• Choice of medical (including prescription), dental, and vision plans with nationwide coverage and telemedicine options.
• Company-provided life and accidental death insurance.
• Short and long-term disability insurance.
• Retirement plan with generous non-discretionary employer contribution and employer match.
• Adoption assistance.
• Wellness programs and employee assistance program (EAP).
• Commuter benefits.
• Various voluntary benefit offerings and discount programs.
• Parental leaves.

Schedule

Night shift: 7:00 PM – 7:30 AM on a 2-2-3 rotation schedule.