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Document Control Specialist

4 months ago

Manassas, United States Catalent Full time

***

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.
- 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 clin