Documentation Specialist
GForce Life Sciences, Scarborough, ME, United States
Responsibilities
Review and process change requests for new documents and revisions to existing documents. Process, organize, and maintain the Document Control System in accordance with applicable quality and regulatory guidelines. Review, edit, and approve or reject Quality System documents; ensure changes are appropriate, justified, and approved by required functional areas according to established procedures. Review documents for consistency with similar or related product specifications and labeling. Secure and control access of documentation as required by established procedures. Communicate and coordinate documentation approvals with other sites. Participate on cross-functional project teams. Follow EHS rules and procedures; report EHS incidents and/or unsafe acts and conditions promptly to supervision; forward opportunities to improve the EHS program to supervision. Implement and maintain the effectiveness of the Quality System. Ensure accuracy of documentation, as product quality is directly linked to associated documentation. Perform other duties and responsibilities as assigned. Qualifications
Minimum of 2 or more years of relevant work experience or exposure within a regulated environment. Associate’s Degree or equivalent combination of education and work experience; Bachelor’s Degree preferred and may account for experience requirement. Ability to clearly, concisely, and accurately convey communications. Ability to influence and provide leadership related to documentation requirements. Ability to form and develop interpersonal, professional relationships. Display socially and professionally appropriate behavior. Ability to work independently and in groups. Demonstrated initiative and problem-solving skills. Strong critical-thinking skills. Ability and aptitude to use various types of databases and other computer software. Ability to prioritize tasks effectively. Strong organizational skills and ability to manage projects. Ability and aptitude to provide solutions and contingency plans through a comprehensive review of alternatives.
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Review and process change requests for new documents and revisions to existing documents. Process, organize, and maintain the Document Control System in accordance with applicable quality and regulatory guidelines. Review, edit, and approve or reject Quality System documents; ensure changes are appropriate, justified, and approved by required functional areas according to established procedures. Review documents for consistency with similar or related product specifications and labeling. Secure and control access of documentation as required by established procedures. Communicate and coordinate documentation approvals with other sites. Participate on cross-functional project teams. Follow EHS rules and procedures; report EHS incidents and/or unsafe acts and conditions promptly to supervision; forward opportunities to improve the EHS program to supervision. Implement and maintain the effectiveness of the Quality System. Ensure accuracy of documentation, as product quality is directly linked to associated documentation. Perform other duties and responsibilities as assigned. Qualifications
Minimum of 2 or more years of relevant work experience or exposure within a regulated environment. Associate’s Degree or equivalent combination of education and work experience; Bachelor’s Degree preferred and may account for experience requirement. Ability to clearly, concisely, and accurately convey communications. Ability to influence and provide leadership related to documentation requirements. Ability to form and develop interpersonal, professional relationships. Display socially and professionally appropriate behavior. Ability to work independently and in groups. Demonstrated initiative and problem-solving skills. Strong critical-thinking skills. Ability and aptitude to use various types of databases and other computer software. Ability to prioritize tasks effectively. Strong organizational skills and ability to manage projects. Ability and aptitude to provide solutions and contingency plans through a comprehensive review of alternatives.
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