What are the responsibilities and job description for the Document Control position at Actalent?
Equivalent Experience
DESCRIPTION:
Responsible for executing the change control processes to ensure standardization, accuracy, and completeness of documents prior to release.
Represents Quality Assurance (QA) and interacts with cross-functional departments to provide quality system guidance. They are responsible for maintaining Master Control and performing tasks related to continuous improvement of this document control system Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.
RESPONSIBILITIES:
Create and maintain Document Control quality system procedures and quality documents Maintain controlled copies of quality documents in the files and in electronic databases Index, file, archive, and manage off-site storage-controlled copies of quality records and other corporate records
Execute change control processes ensuring accuracy and completeness of documents prior to release
Collaborate with other teams in the timely processing of protocols, reports and other design control and process validation activity
Guide cross-functional teams in good documentation practices Support maintenance of design history files, device master records, and technical files
Support Operations in part number control and BOM maintenance in the ERP system as a result of an approved change order
Provide training to new and current employees on how to use MasterControl for processing change orders
Facilitates document retrieval during regulatory inspections Support
quality system audits by providing requested change orders.
Other duties may be assigned
POSITION REQUIREMENTS:
Associates degree or higher is preferred Experience working in an FDA regulated environment and in the IVD industry is preferable.
1-2 years of document control experience or similar industry experience is preferable.
Experience with Master Control a plus.
Experience with ERP system a plus. Skills – Technical Proficient in Microsoft
Office, especially Word and Excel, for editing and tracking documents.
Experience with Document and Change Control electronic systems (preferably Master Control)
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
DESCRIPTION:
Responsible for executing the change control processes to ensure standardization, accuracy, and completeness of documents prior to release.
Represents Quality Assurance (QA) and interacts with cross-functional departments to provide quality system guidance. They are responsible for maintaining Master Control and performing tasks related to continuous improvement of this document control system Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.
RESPONSIBILITIES:
Create and maintain Document Control quality system procedures and quality documents Maintain controlled copies of quality documents in the files and in electronic databases Index, file, archive, and manage off-site storage-controlled copies of quality records and other corporate records
Execute change control processes ensuring accuracy and completeness of documents prior to release
Collaborate with other teams in the timely processing of protocols, reports and other design control and process validation activity
Guide cross-functional teams in good documentation practices Support maintenance of design history files, device master records, and technical files
Support Operations in part number control and BOM maintenance in the ERP system as a result of an approved change order
Provide training to new and current employees on how to use MasterControl for processing change orders
Facilitates document retrieval during regulatory inspections Support
quality system audits by providing requested change orders.
Other duties may be assigned
POSITION REQUIREMENTS:
Associates degree or higher is preferred Experience working in an FDA regulated environment and in the IVD industry is preferable.
1-2 years of document control experience or similar industry experience is preferable.
Experience with Master Control a plus.
Experience with ERP system a plus. Skills – Technical Proficient in Microsoft
Office, especially Word and Excel, for editing and tracking documents.
Experience with Document and Change Control electronic systems (preferably Master Control)
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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