Job Description Role and Responsibilities

This position is responsible for performing quality control laboratory testing on incoming, in-process and finished products and assisting in laboratory operations. The focus of the position is compliance with regulatory activities and company procedures as they relate to the laboratory department. This position reports to the Laboratory Manager and Director of Quality.

Responsibilities include:

• Conduct chemical and biological testing per Laboratory Operating Procedures (LOPs) and regulatory requirements including microbial sequencing, gram staining, endotoxin, and pH.
• Maintain daily use, maintenance and cleaning logs for general laboratory areas, equipment, and utensils.
• Complete routine preventative maintenance of laboratory equipment to ensure accuracy of results.
• Prepare Certificates of Analysis for Quality review.
• Perform data entry, trending, and record organization.
• Support in drafting and reviewing procedures, change controls, risk assessments, deviations and CAPA.
• Assist in quality duties by performing incubator temperature verification and incoming material inspection.
• Participate in test method and equipment validations.
• Ensure compliance to federal and state laws, as well as company standards and specifications.
• Assists the Quality Laboratory Manager as needed

Qualifications and Education Requirements

• Bachelor’s degree in Biology or other scientific studies or equivalent experience in the field.
• Experience running common laboratory equipment including micropipettes, centrifuges, and biological safety cabinets.
• Use good documentation skills/organizational skills to record lab procedures and results.
• Critical thinking and decision-making skills to consider the strengths and weakness of an assay.
• General knowledge of qualitative and quantitative chemistry, mathematics, and biological principles.
• Occupational hazards and standard safety practices.
• Familiarity with compendial testing and regulatory guidance.

Preferred skills

• Experience working in a Federally Regulated Facility

Additional Notes

• Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
• Potential exposure to chemicals used in during assay preparation (special safety precautions must be taken when working with these chemicals)
• Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned
• Must be comfortable and able to don personal protective equipment (PPE), such as gloves, safety goggles and lab coat.

Job Type: Full-time

Pay: From $23.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Golden, CO 80401: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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