Quality System Document Control
This position provides professional and efficient support to the document control team, including receiving, reviewing, categorizing, posting, filing and tracking documents.
Key Accountabilities
General
Interact with global stakeholders and employees at all levels of the organization to facilitate completion of document reviews and approvals.
Ensure documents comply with company standards and applicable procedures.
Follow all applicable company procedures.
Maintain confidential information.
Support the use of the Inotiv documentation control system.
Support any special projects assigned to the document control team as requested.
Other special projects and duties as assigned.
Specific
Work with internal stakeholders to create, revise, review, and release requested documents.
Ensure the proper formatting of documents before approval in the document control system.
Track and manage document lifecycle activities as required by the document control system.
Prepare and route documents for review and/or approval.
Convert documents to appropriate format for general distribution and use.
Prepare and distribute documents for release for use.
Remove obsolete documents from use and archive for retention.
Mentor and assist document owners and users in the execution of the document control process.
Update and maintain documentation master lists and other applicable tracking tools.
Support implementation and maintenance of QMS document control software application.
Minimum Requirements
Education and Experience
Bachelor’s Degree, preferably in English or technical writing discipline, with minimum of 1 year work experience OR 2+ years direct work experience in technical writing or document management within a scientific and/or regulated industry.
Equivalent combination of related education and required work experience will be considered.
Ability to read, write, speak, and understand English.
Organized work habits and the ability to multi-task is required.
Skills and Abilities
Strong understanding of detailed requirements, methodology, and approach for managing and controlling documents within a formal QMS.
Proficient in the use of computer applications including MS Word, MS Excel, MS Teams, MS Outlook, SharePoint and Adobe Acrobat.
Ability to communicate and resolve document control issues with document owners and approvers.
High attention to detail.
Ability to work on multiple tasks and prioritize work.
Excellent verbal and written communication skills.
Working Conditions & Physical Requirements
Sitting for extended periods of time, talking for extended periods of time, reaching while standing and general repetitive motions, especially as related to computer work.
Ability to read and interpret materials, verbally communicate, and hear required.
Office environment.
Moderate noise level.
Critical Success Factors
Communication. Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication. Able to convey complex information clearly. Anticipates the information that others will need. Expresses ideas effectively. Practices attentive and active listening.
Collaboration. Actively supports and contributes to the success of the team. Actively encourages and practices collaboration and cooperation on the team. Shares information and supports other team members. Can get things done with and through others and set realistic objectives. Seeks opportunities to develop others.
Relationship Builder. Develops, maintains, and strengthens strong partnerships with others internally and externally, cross functionally, in person and remotely.
Improvement Driven. Inspires and generates new solutions and approaches to issues and challenges to maximize efficiency and effectiveness through everyday practice of root cause analysis and critical thinking problem solving; Continually works to refine skills and abilities; Builds on ideas of others to come up with new ways to address issues or problems; Generates creative new solutions and approaches to issues and processes.
Organization and Time Management. Plans and prioritizes work, manages time appropriately to meet deadlines, follows up with others to ensure one’s own work and commitments are completed on time, deals with pressure and deadlines through good planning.
*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.
Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.
Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!
Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.
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Key Accountabilities
General
Interact with global stakeholders and employees at all levels of the organization to facilitate completion of document reviews and approvals.
Ensure documents comply with company standards and applicable procedures.
Follow all applicable company procedures.
Maintain confidential information.
Support the use of the Inotiv documentation control system.
Support any special projects assigned to the document control team as requested.
Other special projects and duties as assigned.
Specific
Work with internal stakeholders to create, revise, review, and release requested documents.
Ensure the proper formatting of documents before approval in the document control system.
Track and manage document lifecycle activities as required by the document control system.
Prepare and route documents for review and/or approval.
Convert documents to appropriate format for general distribution and use.
Prepare and distribute documents for release for use.
Remove obsolete documents from use and archive for retention.
Mentor and assist document owners and users in the execution of the document control process.
Update and maintain documentation master lists and other applicable tracking tools.
Support implementation and maintenance of QMS document control software application.
Minimum Requirements
Education and Experience
Bachelor’s Degree, preferably in English or technical writing discipline, with minimum of 1 year work experience OR 2+ years direct work experience in technical writing or document management within a scientific and/or regulated industry.
Equivalent combination of related education and required work experience will be considered.
Ability to read, write, speak, and understand English.
Organized work habits and the ability to multi-task is required.
Skills and Abilities
Strong understanding of detailed requirements, methodology, and approach for managing and controlling documents within a formal QMS.
Proficient in the use of computer applications including MS Word, MS Excel, MS Teams, MS Outlook, SharePoint and Adobe Acrobat.
Ability to communicate and resolve document control issues with document owners and approvers.
High attention to detail.
Ability to work on multiple tasks and prioritize work.
Excellent verbal and written communication skills.
Working Conditions & Physical Requirements
Sitting for extended periods of time, talking for extended periods of time, reaching while standing and general repetitive motions, especially as related to computer work.
Ability to read and interpret materials, verbally communicate, and hear required.
Office environment.
Moderate noise level.
Critical Success Factors
Communication. Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication. Able to convey complex information clearly. Anticipates the information that others will need. Expresses ideas effectively. Practices attentive and active listening.
Collaboration. Actively supports and contributes to the success of the team. Actively encourages and practices collaboration and cooperation on the team. Shares information and supports other team members. Can get things done with and through others and set realistic objectives. Seeks opportunities to develop others.
Relationship Builder. Develops, maintains, and strengthens strong partnerships with others internally and externally, cross functionally, in person and remotely.
Improvement Driven. Inspires and generates new solutions and approaches to issues and challenges to maximize efficiency and effectiveness through everyday practice of root cause analysis and critical thinking problem solving; Continually works to refine skills and abilities; Builds on ideas of others to come up with new ways to address issues or problems; Generates creative new solutions and approaches to issues and processes.
Organization and Time Management. Plans and prioritizes work, manages time appropriately to meet deadlines, follows up with others to ensure one’s own work and commitments are completed on time, deals with pressure and deadlines through good planning.
*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.
Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.
Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!
Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.
Apply To This Job