Computer Software Validation Coordinator

Provident Nutraceutical a division of Ortho Molecular Products
Job Description
Ortho Molecular Products is an exciting growth-oriented company, dedicated to transforming the practice of medicine.  We develop our formulas using the most well-researched and efficacious ingredients in a cGMP, FDA-audited manufacturing facility that is based in Stevens Point, Wisconsin.  We are currently searching for an experienced and passionate Computer Software Validation Coordinator to join our team!  At Ortho Molecular Products, you will have the opportunity to work on new and exciting projects and develop your career.

This position is responsible for computer systems validation (CSV) activities that manage, maintain and improves the company’s quality program.  Qualified candidates must be experienced in drafting, reviewing and approving projects to assure that these systems are compliant with company and regulatory standards through computer software validation projects.

RESPONSIBILITIES:
  • Strong Knowledge of 21 CFR part 11 including: electronic records, electronic signatures, audit trail, access security, back up/disaster recovery, etc.
  • Coordination, assisting and documenting computer validation activities; preparation/approval of protocols and reports.
  • Drafting, reviewing and approving validation and compliance documents supporting GMP computerized systems, including SOP’s, qualification protocols, gap assessments, risk/hazard assessment, impact assessment, user requirements, functional and design/configuration specifications, IQ/OQ/PQ, validation plans, validation summary reports and change controls.
  • Preparing, assisting, or participating in system design, specification development, and design review.
  • Ability to apply complex system validation principles to work assignments.
  • Establishes priorities and schedule activities to ensure timeliness and milestones are met.
  • Must be able to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems.
  • Provides training to employees on systems and validation sops.
  • Coordinates meetings, documents issues, action items, and performs appropriate follow up related to CSV projects.
  • Reviews, understands, and ability to apply regulations related to dietary supplement good manufacturing practices (GMP’s), and validation guidance documents.
  • Assists in creating and revising controlled documents (ex: SOPs, forms) in compliance with internal standards as well as external regulatory requirements.
  • Execute external vendor audits as required to support computer system validation.
QUALIFICATIONS:
  • BS/BA degree in a related science, computer science, technology field or 2-4 years’ experience in related science/business field required.
  • Basic knowledge of quality systems and computer system validation
  • Basic knowledge of Good Manufacturing Regulations.
  • ASQ certification desirable.
  • Proficient in the Microsoft Office Suite (includes Word, Excel, Access and PowerPoint); experience in SharePoint and ERP systems desired.
  • Ability to read and comprehend instructions, memos, emails, SOP’s and other materials required.Ability to write legible correspondence.Ability to effectively present information verbally to other employees of the organization. Must effectively demonstrate the ability to communicate in English, both verbally and in written format.
  • Ability to add, subtract, and multiply applying statistical mathematical concepts when needed.
  • Ability to apply common sense understanding and carry out instructions furnished in written and oral form.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is required to sit, stand, walk, lift and talk or hear.The employee is required to use hands to finger, handle, or feel objects, or controls; reach with hands and arms.Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The noise level in the work environment is usually moderate to quiet.
BENEFITS:
  • Health and dental insurance
  • Voluntary benefits (accident insurance, disability insurance, vision insurance, etc.)
  • 401(k) with company match
  • Bonus Opportunities
  • Corporate wellness program
  • Gym membership
  • Ample paid time off
  • Opportunity for growth  
This is an excellent opportunity for an individual to contribute and make an impact, stop working at a job and start your career with Ortho Molecular Products. Apply today with your updated resume!

 
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