Quality Assurance Specialist I

Company: Disability Solutions
Location: Manassas
Posted on: February 2, 2025

Job Description:

Quality Assurance Specialist IPosition SummaryCatalent, 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 the work environment is usually moderate to loud. The position requires working in a humid and warm environment. 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. The position requires a great deal of walking and standing, approximately 85%.Why you should join Catalent:
    • Defined career path and annual performance review and feedback process--
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--
    • Dynamic, fast-paced work environment
    • Generous 401K match and Paid Time Off accrual--
    • Medical, dental and vision benefits effective day one of employment--
    • Tuition Reimbursement--
    • Wellhub program to promote overall physical wellness--
    • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories--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.Visit to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.--------Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Harrisonburg , Quality Assurance Specialist I, Other , Manassas, Virginia