Quality Control Technician (CO, Golden)

Responsibilities

• Adhere to Good Documentation Practices (GDPs)
• Incoming materials receipt: inspect, document, unpack, label, shelve, and organize materials
• Obtain samples of raw, in-process, and finished goods materials and send to third party labs for testing. Results to be entered into applicable spreadsheets
• Review Logs of Use and Maintenance (LUMs) for accuracy and GDP
• Create Certificate of Analysis
• AQL Inspection
• Perform Quality checks on in-process product and facility controls as needed
• Sterilization: Prepare, receive, and organize product for sterilization
• Environmental Monitoring (EM): Collect routing EM samples. Enter, report and trend sample data
• Identify nonconformances and escalate to leadership
• Attend all required meetings and provide clear, professional verbal and email communications
• Special projects as assigned by Management
• Other duties as assigned

Qualifications and Education Requirements

• Bachelor’s degree or higher (preferred) in science, or similar
• At least one year (preferred) of practical experience of in a Quality role in an FDA regulated company. Show a progression in various Quality roles within the pharmaceutical industry, medical device or similar
• Experience working to cGMP guidelines and demonstrates expertise in variety of the field’s concepts, practices, and procedures
• Experience working with Production or Manufacturing
• Must exhibit excellent verbal and written communication skills
• Must exhibit excellent attention to detail
• Must pass an eye exam confirming 20/20 near vision corrected (with contact or glasses) or uncorrected
• Must pass an eye exam confirming the ability to accurately perceive color
• Multitasking skills
• Good computer skills (data entry, Microsoft Office products, email, internet, HR Software, and inventory management software systems)
• Ability to work as part of a small team in a fast-paced environment
• Excellent work ethic
• Familiarity with FDA, cGMP, and USP / is a strong asset

Additional Notes

• Must be able to gown for ISO 8 area
• This position may require the handling of laboratory chemicals. Potential exposure to chemicals used in the preparation of compounds (some chemicals are classified as toxic and special safety precautions must be taken when working with these chemicals)
• 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
• Must be able to use necessary equipment such as computers, scanners, phone/headset, or other technology devices as assigned