Quality Technician
Role and Responsibilities
This position is responsible for working cross functionally to support Quality Assurance & Quality Control tasks, with potential placement in a specialty area. The Quality Technician will support Belmar Pharma Solutions in carrying out the mission of the company. This position reports to the Quality Manager.
Responsibilities include:
Understanding and managing Inventory Control
Create & review all labels (in-process and finished goods) and Batch Production Records for accuracy and adherence 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
Finished drug product batch release checks
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
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
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
Job Type: Full-time
Pay: $20.00 - $25.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Experience:
Quality: 1 year (Required)
GMP: 1 year (Required)
Pharmaceuticals: 1 year (Required)
Ability to Commute:
Golden, CO 80401 (Required)
Work Location: In person