What are the responsibilities and job description for the Document Control Specialist position at Advanced Clinical?
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Document Control Specialist onsite, in Trumbull, CT. The Document Control Specialist role will be responsible for the maintenance and management of controlled documents and records for the Client as well as provide administrative support to the quality assurance team. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Assist with Quality Systems Procedure revision as part of an integration process: keeping track of originating procedures and the new / integrated procedures as well as all related documents (manuals, forms, flowcharts)
* Facilitate the electronic document control process regarding new or existing Quality System Documents, and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired / obsolete, etc.
* Work with owners/originators, reviewers and approvers to facilitate document control workflow, ensuring proper document formatting and organization
* Ensure right-first-time review prior to formal review process, by quality management, to ensure good documentation practices, readability (clear and concise) and compliance with internal standards. This includes reporting gaps to senior management and providing guidance to document owners regarding how to create, remediate or correct documents
* Maintain document security
* Coordinate Periodic Review of Documents to owners
* Upload existing/new revision documents to the PLM
* Conduct training for new and existing employees on electronic quality management system
* Locate, review, submit, and reconcile document/record requests during audits
* Ensure timely response to documentation requests for audits
* Prepare welcome packet folders for upcoming audits
EXPERIENCE
Minimum of 2-5 years of experience with ISO13485 standards
EDUCATION
Minimum of High School Diploma or equivalent combination of education and experience
To be a best-fit your strengths must include:
* Ability to meet deadlines and perform administrative functions
* Microsoft Office suite proficiency preferred
* Must be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignments and changing business needs.
* Ability and willingness to travel between locations when business needs dictate
* Able to travel both domestically and internationally including overnight stays
* Must be able to read, write, speak, fluently and comprehend the English language
About Advanced Clinical
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
Equal Employment Opportunity
It is Advanced Clinical's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
We are currently searching for a skilled professional to join a well-known client's team as a Document Control Specialist onsite, in Trumbull, CT. The Document Control Specialist role will be responsible for the maintenance and management of controlled documents and records for the Client as well as provide administrative support to the quality assurance team. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Assist with Quality Systems Procedure revision as part of an integration process: keeping track of originating procedures and the new / integrated procedures as well as all related documents (manuals, forms, flowcharts)
* Facilitate the electronic document control process regarding new or existing Quality System Documents, and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired / obsolete, etc.
* Work with owners/originators, reviewers and approvers to facilitate document control workflow, ensuring proper document formatting and organization
* Ensure right-first-time review prior to formal review process, by quality management, to ensure good documentation practices, readability (clear and concise) and compliance with internal standards. This includes reporting gaps to senior management and providing guidance to document owners regarding how to create, remediate or correct documents
* Maintain document security
* Coordinate Periodic Review of Documents to owners
* Upload existing/new revision documents to the PLM
* Conduct training for new and existing employees on electronic quality management system
* Locate, review, submit, and reconcile document/record requests during audits
* Ensure timely response to documentation requests for audits
* Prepare welcome packet folders for upcoming audits
EXPERIENCE
Minimum of 2-5 years of experience with ISO13485 standards
EDUCATION
Minimum of High School Diploma or equivalent combination of education and experience
To be a best-fit your strengths must include:
* Ability to meet deadlines and perform administrative functions
* Microsoft Office suite proficiency preferred
* Must be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignments and changing business needs.
* Ability and willingness to travel between locations when business needs dictate
* Able to travel both domestically and internationally including overnight stays
* Must be able to read, write, speak, fluently and comprehend the English language
About Advanced Clinical
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
Equal Employment Opportunity
It is Advanced Clinical's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
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