Catalent Inc
Quality Assurance Specialist I - Quarantine
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 - Quarantine, is responsible for sampling and testing of inbound raw materials and packaging materials to ensure adherence to company quality standards. Communicate any deviations to management. The Quality Assurance Specialist I - Quarantine will assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards. This position is 100% based on-site in Manassas, VA. The Role
Responsible for managing the Quarantine process. Responsible for reviewing incoming materials' COAs. Manages and reviews incoming labels and packaging materials. Review of receiving documentation. Responsible for maintaining Raw Materials and Finished Goods' Quarantine log. Sampling incoming raw materials and sending to 3rd party laboratory. Performs in-house identification testing of Raw Materials. Logs and ships Finished Goods samples to contract laboratories. Responsible for receiving lab reports and using them to create finished products COAs. Responsible for holding products that do not meet company quality standards and provide the appropriate dispositions. Other duties as assigned. The Candidate
This position requires BS in Food Science and/or related major or have High School diploma/GED with significant experience in manufacturing and training - HACCP, PCQI, GFSI, cGMP. For business and safety reasons, must be able to communicate effectively verbally and in written English. Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers. Strong analytical skills. Ability to read and follow documents (Standard Operating Procedures and Test Methods). Knowledge of GMP and Quality systems. Knowledge of spoken Spanish is a plus. The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb or balance and taste or smell. Why You Should Join Catalent
Competitive medical benefits and 401K 152 hours of PTO + 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Personal initiative. Dynamic pace. Meaningful work. Catalent is an Equal Opportunity Employer, including disability and veterans.
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 - Quarantine, is responsible for sampling and testing of inbound raw materials and packaging materials to ensure adherence to company quality standards. Communicate any deviations to management. The Quality Assurance Specialist I - Quarantine will assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards. This position is 100% based on-site in Manassas, VA. The Role
Responsible for managing the Quarantine process. Responsible for reviewing incoming materials' COAs. Manages and reviews incoming labels and packaging materials. Review of receiving documentation. Responsible for maintaining Raw Materials and Finished Goods' Quarantine log. Sampling incoming raw materials and sending to 3rd party laboratory. Performs in-house identification testing of Raw Materials. Logs and ships Finished Goods samples to contract laboratories. Responsible for receiving lab reports and using them to create finished products COAs. Responsible for holding products that do not meet company quality standards and provide the appropriate dispositions. Other duties as assigned. The Candidate
This position requires BS in Food Science and/or related major or have High School diploma/GED with significant experience in manufacturing and training - HACCP, PCQI, GFSI, cGMP. For business and safety reasons, must be able to communicate effectively verbally and in written English. Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers. Strong analytical skills. Ability to read and follow documents (Standard Operating Procedures and Test Methods). Knowledge of GMP and Quality systems. Knowledge of spoken Spanish is a plus. The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb or balance and taste or smell. Why You Should Join Catalent
Competitive medical benefits and 401K 152 hours of PTO + 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Personal initiative. Dynamic pace. Meaningful work. Catalent is an Equal Opportunity Employer, including disability and veterans.