Quality Control Lab Technician

Job Description

As a Quality Control Analyst, you will be responsible for testing raw materials and finished products in our Quality Control laboratory.

Responsibilities

• Conduct routine and non-routine chemistry and microbiological analysis of raw materials, in-process formulations, and final products to established specifications.
• Utilize and operate laboratory equipment and instruments according to laboratory work instruction or laboratory procedures such as pH, conductivity, UV, KF, FTIR, and titrations.
• Understand and follow Quality Control test methods or compendia methods (USP, EP, BP, JP, or ACS) and EXCIPACT standard.
• Calculate and generate data for compliance to specifications and report results.
• Perform technical review of lab data forms such as water, environmental monitoring, and direct measure analysis.
• Calibrate and maintain lab equipment.
• Enter final results and raw data for tested materials or products in LIMS (Laboratory Information Management System) as needed.
• Perform investigative analysis to support investigations, complaints, or instrument troubleshooting.
• Perform Environmental Monitoring duties, which require gowning into cleanroom and collection of air and surface samples while in the cleanrooms.
• Review for discrepancies in data, manufacture COA, COC, and perform data verification in accordance with company procedures.
• Apply appropriate disposition labels to materials (accepted, rejected, etc.).
• Handle hazardous materials using all appropriate or mandatory safety PPE and safety equipment.
• Complete documentation in a legible manner and review for accuracy.
• Perform sampling and testing for USP Purified water and Water for Injection.
• Author, review, or update lab procedures and Lab instruments Work Instructions.
• Perform microbiological tests such as bioburden, endotoxin, Dnase, Rnase, Protease, and Phosphatase using proper aseptic techniques.
• Prepare and properly dispose of microbial media.

Essential Skills

• Quality control
• GMP
• Laboratory
• Chemistry
• Microbiology
• HPLC
• Quality assurance
• Biology
• Environmental monitoring
• Biochemistry
• Wet chemistry

Additional Skills & Qualifications

• Bachelor's degree in a science discipline with knowledge and experience in Chemistry, Biology, or related fields.
• 3 years of laboratory experience in a related field.
• Wet chemistry and microbial testing experience preferred (e.g., Acid/Base Titrations, water content, Bioburden, Endotoxin).

Work Environment

Typically works in a lab and office environment with adequate lighting and ventilation and a normal range of temperature and noise level. At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers, and others. Work assignments are diversified, with examples of past precedent used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on a routine basis. Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs.