POSITION SUMMARY

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 auditing the products and processes at various points in the areas of production and packaging to ensure adherence to company quality standards. Communicate any deviations to management. Assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.

Hours: Monday-Friday 10AM-6PM. Provide coverage during production runs on extended shifts and weekends, as needed.

Location: Manassas, VA - this is a site based position

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The Role:

• Responsible for managing the Quarantine process and for reviewing incoming materials’ COAs; Manages and reviews incoming labels and packaging materials and well as reviews receiving documentation.

• Responsible for maintaining Raw Materials and Finished Goods’ Quarantine log; Samples incoming raw materials and sending to 3rd party laboratory. Also performs in-house identification testing of Raw Materials.

• Logs and ships Finished Goods samples to contract laboratories and is 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. Must report any deviations to QA Supervisor in complete appropriate details; Document all areas of non-compliance and ensure corrective action to eliminate them.

• Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards and responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training; Responsible for ensuring Dietary Supplement’s Identity, Purity, Strength and Quality; Ensures accurate and timely completion of all tasks relating to issuance of Batch production records and maintenance of cGMP and SOP records.

• Participates in all necessary training required to successfully perform job responsibilities.

• Other duties as assigned.

The Candidate:

• BS in Food Science and/or related major preferred or must have high school diploma

• Must have significant experience in manufacturing and training - HACCP, PCQI, GFSI, cGMP; Must have ability to read and follow documents (Standard Operating Procedures and Test Methods) and Knowledge of GMP and quality systems

• For business and safety reasons, must be able to communicate effectively verbally and in written English; Ability to communicate with all line level positions and management; Knowledge of spoken Spanish is a plus

• Must have a strong attention to detail, able to assert himself / herself effectively, have strong problem-solving skills and have strong analytical skills

• Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers.

• 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

• 19 days of PTO + 8 paid holidays

• Tuition Reimbursement

• GymPass 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .