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Quality Control Specialist

JOB OVERVIEW:
The Quality Control Specialist is a vital position in the operations of Celltex’s laboratory. The primary responsibility of the QC Associate II is to test and inspect the environment, materials, and samples to ensure the quality of product and to ensure compliance with cGMP.

JOB DUTIES:

• Understand cGMP/GLP guidelines and regulatory procedures, including but not limited to 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211.
• Maintain compliance with cGMP/GLP guidelines and apply them at all times
• Follows Celltex’s Quality Control SOPs, policies and procedures
• At all times, effectively use and maintain proper aseptic techniques
• Demonstrate proficiency in good documentation practices
• Log, document, and verify the receipt of incoming specimens
• Performs Celltex QC testing such as sterility USP <71>, endotoxin USP <85>, mycoplasma, gram stain, product appearance, cell counting, viability and others required by QC SOP, and complete all assigned tasks on time per team schedule
• Review documents and write Certificate of Analysis for final product
• Performs Environmental Monitoring of GMP Facilities including air, surface, and personnel monitoring
• Trend and analyze Environmental Monitoring/Personnel Monitoring data
• Train new employees for QC related tests and maintain training file for review
• Participate in writing and revising SOPs
• Identify and report problems to the QC Manager. Performs laboratory investigations and OOS and OOT analysis, assist with follow-up of alert limit.
• Performs sub-cultures of questioned sample, ship for identification and reviews data
• Write Deviation/OOS investigation reports
• Document and maintain LUMACs on assigned equipment and laboratory areas
• Participate in Quality Control validations/verifications, calibrations, and qualifications as needed
• Performs Weekly and Monthly clean of laboratory equipment and lab areas.
• Always maintain the cleanliness of QC laboratory.
• Attend and participate in group and project meetings
• Recommend changes to any process or task to increase efficiency and decrease costs
• Works with manufacturing and Quality assurance department, and correspondence/collaboration with other departments.
• Maintain required material inventory levels for Quality control department.
• Performs other duties as assigned by QC manager.

EDUCATION/EXPERIENCE AND SKILL REQUIREMENTS:

• Bachelor’s degree in biology, microbiology, or other relevant life science field, and at least three years of experience in cGMP
• Experience with microbiology laboratory techniques preferred.
• Exemplary, focused and unbiased attention to detail
• Excellent communication and interpersonal skills
• Ability to work in a fast-paced environment
• Ability to creatively manage time and elevate relevant issues to management.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Must be able to work around bio-hazardous materials (ex., human adipose tissue) and chemicals (ex., disinfectant and sporicidal agents
• Must be able to lift 20 lbs.
• Must be able to work in a cleanroom environment with full personal protective equipment.
• Must be willing to work on weekends and or holidays if needed.

REPORTS TO: Quality Control Manager

DEPARTMENT: Operations – Quality Control

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Celltex Therapeutics Corporation is a U.S. Equal Opportunity Employer.