Document Control Specialist I

Primary Talent Partners•Round Lake, IL

About The Position

Primary Talent Partners is hiring a Document Control Specialist I on a 3-month W2 contract, with potential for extension, for a healthcare client in Round Lake, Illinois. The role reviews and approves GMP/GLP manufacturing and related documentation to support timely product and system release. It also supports internal audits, engineering documentation and configuration work, documentation systems, training on documentation and labeling processes, and project teams as needed. The position is scheduled Wednesday through Sunday, 8:00 a.m. to 5:00 p.m. Pay is $20.00–$21.33 per hour. The posting states that the contract has no PTO or benefits; an ACA-compliant supplemental package is available for enrollment. Candidates must be legally authorized to work in the United States and able to work on Primary Talent Partners’ W2 without sponsorship.

Requirements

  • Bachelor of Arts or Bachelor of Science degree and 3–5 years of related experience, acquired in-house or externally.
  • Knowledge of product/document configuration management and working knowledge of related business systems.
  • Intermediate document-management and software skills, including tools such as Word.
  • Knowledge of FDA regulations and applications of Good Laboratory Practices and Good Manufacturing Practices.
  • Comprehension of design methodology, product configuration, and complex manufacturing processes.
  • Project management skills and the ability to discuss normally encountered technical or project management issues verbally and in writing.
  • Excellent conceptual, analytical, written, and verbal configuration skills.
  • Ability to work under strict deadlines and changing priorities with minimal supervision, handle multiple projects concurrently, and use a computer.
  • Strong interpersonal skills, attention to detail, teamwork, problem-solving, and verbal and written communication skills.
  • Must be legally authorized to work in the United States and able to work on Primary Talent Partners’ W2 without sponsorship.

Responsibilities

  • Review and approve GMP/GLP manufacturing and related documentation to support timely product and system release.
  • Conduct internal audits of SOPs, training records, and other document types as needed.
  • Assist and guide engineering in preparing product documentation, product configuration, and document change request packages.
  • Perform activities to provide required documentation and implement related documentation systems.
  • Assist with training on documentation and labeling processes and systems; help create training materials and train internal and external personnel.
  • Participate on project teams as needed and aid in executing user acceptance testing.
  • Maintain and own internal documents, including proofreading and making changes as needed.
  • Review documentation for accuracy and procedural compliance; route, release, or reject it as appropriate, and ensure document and system elements are identified, accurate, and assembled for review and approval.

Benefits

  • An ACA-compliant supplemental package is available for enrollment.
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