Document Control Specialist

4 weeks ago

Greendale, United States Disability Solutions Full time

Document Control Specialist

Position Summary

  Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

Greendale is one of two gummy technology development and manufacturing facilities in North America. The site has the capability to manufacture traditional gelatin gummies as well as 100% plant-based pectin gummies for nutritional supplements and nutraceuticals. With extensive development and manufacturing expertise and a wide range of flavors, shapes, sizes, and colors available, we can work with complex ingredients to help create engaging new products consumers will love.

 

The Document Control Specialist is responsible for creation and maintenance of the Quality System documentation. Communicate any deviations to management. The Document Control Specialist assists the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards. Regular working hours for this role are M-F 8am-5pm.

 

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. Complying with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.
  • Manage the routing and approval process for new documents and process deviations.
  • Manage collection and shipment for third party lab testing samples.
  • 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.
  • 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.
  • Participate in all necessary training is required to successfully perform job responsibilities.
  • Other duties as assigned: The position and its essential functions may change over time and these changes may not necessarily be reflected in the position description. The Company may, at its sole discretion, add to, change, or expand the essential or marginal functions of this position.

 

The Candidate

  • HS or equivalent required with a minimum of 2 years supporting the creation and maintenance of all documentation related to a Quality System in a FDA and cGMP environment.
  • BS in Food Science or related major is preferred.
  • 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.
  • 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%.
  • 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.

 

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.

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 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.

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