QC Specialist

QC SPECIALIST JOB DESCRIPTION

Our client is recognized as a certified global leader in medical biotechnologies, specializing in cellular therapies. They are looking for a talented and competitive Customer Care Associate who thrives in a sales/manufacturing industry.

Hours of Operation:  8AM – 4PM OR 9AM – 5PM (Monday – Friday) Onsite
Annual Salary Compensation:  $55,000 - $60,000
Position Reports to: QA Manager

The Quality Control Officer is responsible for maintaining quality control processes, analyzing the results, and giving feedback and guidance to the production team under direct supervision. Ensures and assists in determining if materials, products, and/or processes are in accordance with specifications and ensures the staff follows the set processes and adheres to best production practices and product quality standards.
 

• Approve incoming materials by confirming specifications, conducting a visual and measurement test, and rejecting and returning unacceptable materials.
• Assist in validation of methods.
• Approve in-process production by confirming required specifications, conducting visual and measurement tests, and communicating the required adjustments to the production supervisor.
• Verify all finished products by confirming specifications and conducting required tests.
• Verify and Approve Sterilization Processing Certificate.
• Return products for re-work if needed and complete documentation to confirm re-work.
• Document and update inspection results by completing reports and logs.
• Perform QC testing including LAL testing for manufacturing and validation processes.
• Keep measurement equipment operating by following operating instructions and calling for repairs (calibration plan and records management).
• Maintaining the quality of the laboratory environment including the clean room, laboratory, and QC laboratory (Environmental Control SOP).
• Performs Quarterly low-dose audit and drafting of the final report.
• Plans the scheduling of biocontamination services.
• Other duties as assigned by the Global Chief Operations Officer or QA/RA Manager.

Skills Required:

• High school diploma or general education degree (GED) required.
• Solid understanding of test equipment.
• Minimum of 3-5 years of inspection and/or production experience.
• Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions.
• Ability to lift and/or move up to fifty pounds occasionally.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Demonstrated ability to work independently with minimal supervision.
• Excellent organizational skills.

KEY QUESTIONS:

• High school diploma
• Technical degree (i.e., engineering, mathematics, and/or science)
• Experience with ISO13845
• Basic to intermediate understanding of how to operate test equipment
• 3 to 5 years working in a medical / pharmaceutical company in a quality department
• Experience with ANSI standards for testing
• Familiar working in a clean room
• Communicate to both Brooklyn, NY and a Jersey City, NJ Location
• Possess strong working knowledge of various mathematical concepts including fractions, ratios, and proportions
• Ability to lift and/or move up to 25 to 50 pounds occasionally
• Has worked independently in prior positions with minimal supervision
• Excellent organizational skills
• Knowledge of TAPPI charts for visual inspection of products