This position is responsible for receiving and sampling incoming materials, developing specification sheets for incoming materials, and submitting samples to the laboratory. This position reports to the QC Supervisor and Director of Quality.

Responsibilities include:

• Perform all aspects of incoming materials receipt including documentation, unpacking, labeling, shelving and organization
• Sample raw materials, in-process product and finished goods; sample submission and data entry.
• Create specifications for new incoming raw materials as assigned by Quality Management
• Ability to learn and follow established procedures and guidelines (SOPs) and communicate procedures inter and intra-departmentally in accordance with current Good Manufacturing Practices (cGMP)
• Create batch records for Production processes. Continuously check and verify batch records and associated documentation to ensure that Good Documentation Practices and protocols are followed. Perform Quality checks on batch records to prepare product for batch release.
• Perform visual inspection, Quality checks and verification of in process and finished products
• Organize, prepare and receive product in accordance with sterilization process.
• Assist with data entry, trending and review
• Manage other special projects as required; ensuring tasks are completed in conformance with business and regulatory requirements.
• Ensure compliance to federal and state laws, as well as company standards and specifications.

Qualifications and Education Requirements

• High School Diploma required
• Experience working to cGMP guidelines
• Ability to don personal protective equipment and work in a cleanroom environment for extended periods of time
• Excellent communication skills; both verbal and written
• Experience with Microsoft Office Suite (Word, Excel) and ability to utilize various software programs
• Strong work ethic and attention to detail

Preferred Skills

• Associates Degree
• Experience working in the Pharmaceutical Industry
• Experience working in a Federally Regulated Facility

Additional Notes

• Must be able to lift up to 50 lbs. frequently throughout the day
• 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 wear required PPE for long periods of time when required.
• Position requires handling of laboratory chemicals or hazardous materials

Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned

Job Type: Full-time

Pay: $20.00 - $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Lakewood, CO 80228: Reliably commute or planning to relocate before starting work (Required)

Education:

• Associate (Required)

Work Location: One location

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