Document Control Specialist

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 Document Control Specialist – 2nd Shift is responsible for creating and maintaining the Quality System documentation. Communicate any deviations to management. Assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards.

Shift: 2nd 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

The Role:

Support the creation and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure proper formatting, numbering, and organization of all related documents: MMRs, specifications, BPRs, Food Safety and Quality Plans, and any other documents as required.

Manage the routing and approval process for new documents and process deviations; Perform internal audits and document all non-conformance to support continuous improvement efforts; Document all areas of non-compliance with the Quality System and ensure corrective action is implemented to eliminate them.

Work with Production and Packaging Managers, Supervisors, and R&D to maintain and update records and documentation.

Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards; Responsible for ensuring compliance with FDA and cGMP standards for Quality Control, including continuous training; Responsible for ensuring Dietary Supplement’s Identity, Purity, Strength, and Quality.

Document all areas of non-compliance and ensure corrective actions are completed. Utilize the computer to enter and track result data; Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail; Review and verify the operators' paperwork to ensure they meet quality standards.

Participate in all necessary training required to perform job responsibilities successfully.

Other duties as assigned.

The Candidate:

BS in Food Science and/or related major preferred or high school Diploma with 3+ years of experience in the food industry required.

Ability to read and follow documents (Standard Operating Procedures and Test Methods); Knowledge of GMP and Quality systems.

Basic Microsoft Office (Excel, PowerPoint, and Word) knowledge

Must be able to communicate effectively verbally and in written English; Knowledge of spoken Spanish is a plus.

Strong interpersonal skills are essential. The ability to develop cross-functional and multinational relationships to support interaction with various internal customers is also essential; Ability to communicate with all line-level positions and management.

Attention to detail and self-starter who must be able to work independently with minimum supervision and able to assert themself effectively; Strong analytical skills.

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 move up to 50 pounds. While performing this job's duties, the employee must use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, crawl, and talk or hear. The employee is required to sit, climb, 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 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

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