Quality Assurance Specialist I

Quality Assurance Specialist I

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Manassas provides expanded capabilities in soft chews and lozenges. The site has the capability to manufacture cold-processed soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love.

 The Quality Assurance Specialist I is responsible for inspection and verification of the products and production processes along all the production chain from receiving to dispatching. To ensure adherence to company quality standards procedures and policies. Inform the QA management if any out of specification or any deviations are found. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standard and any other standard that Catalent complies with. Ensure all employees involved with production or contractors inside the production plant are following our cGMP and execute corrective actions when needed. Assist the Quality Assurance team with special projects as required.

This position will be on a floating shift schedule. Typical work week is 40 hrs/per week with fluctuating days and times, overtime eligible and 100% on site at Manassas, VA facility, 

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

• Conduct thorough and detailed quality inspection and check of lines to ensure products meet established quality standards before, during and after production; perform daily checks and inspections to guarantee food safety and well maintenance of the plant infrastructure.
• Equipment verification including metal detector, x-ray, scales, etc.
• Review and verify paperwork of operators to ensure they are meeting quality standards; report any deviations to QA Supervisor in complete appropriate details; report any housekeeping issues that need attention.
• Document all areas of non-compliance and ensure corrective actions are completed. Utilize computer to enter and track result data.
• Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards and any other standard Catalent complies with; responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training.
• Perform cleaning verification by ATP, EMP testing; conduct AQL inspections in and off the line.
• Participate in all necessary training is required to successfully perform job responsibilities; resolve any problem related to the production process under their capabilities; collaborate with production employees and management to resolve any issue during the production process
• Other duties as assigned.

The Candidate:

• BS in Food Science related major with 1+ year experience in quality assurance in a regulated environment OR High School Diploma with 3+ years of experience in regulated environment is required.
• Knowledge of GMP and Quality systems; Ability to read and follow documents (Standard Operating Procedures and Test Methods).
• Basic Microsoft Office (Excel, PowerPoint, and Word).
• Ability to communicate with all line level positions and management; Must be able to communicate effectively verbally and in written English.
• Self-starter and must be able to work independently with minimum supervision and strong attention to detail with strong analytical skills.
• Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers.
• Knowledge of spoken Spanish is a plus
• Work environment: while performing the duties of this job, the employee is regularly exposed to work near moving mechanical parts. The noise level in