The Accuro Group
Biopharmaceutical Technical Writer
The Accuro Group, Marietta, Pennsylvania, United States, 17547
Business Title: 104308 | Technical Writer
Find out more about this role by reading the information below, then apply to be considered.Location: Marietta, PA 17547Job Type: Contract (3 M)
Job Description:
Promote a highly safety conscious culture and EHS focused workforce.Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice.
Job Responsibilities:
Serve as a Technical Writer dedicated to authoring, revising, and improving documents within manufacturing. (Business processes, SOPs, batch records, checklists, etc.)Serve as liaison between manufacturing groups, as well as between manufacturing and support departments, to ensure accurate, compliant, and streamlined controlled documentsDrive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documentsChampion standardization of documents across groups within manufacturing (e.g., content, structure, format, etc.)Serve as a change coordinator for projects in the manufacturing departmentPartner with learning and development as well as Manufacturing groups to ensure documents support accurate representation of operations and provide a foundation for education and competencyFormat and manage documents using appropriate guidelines and established document templatesEvaluate GMP documentation change requests to determine scope of change, and ensure accurate information in revision history (associated CAPAs, Change Controls, Impact Assessments, etc.)Where appropriate, manage CAPA tasks related to GMP documentation revisionsDetermine when GMP documentation duplications exist and manage resolution and consolidation of affected documentsSupport Lean/Six Sigma program to drive and embed a culture of continuous improvement by the use of operational excellence methodologies to realize ever-increasing levels of value in the usability and practicality of documentsPartner with LSOP Process Owners, to obtain accurate content for inclusion in documents, utilizing shop floor Gembas and process walk-downs, to drive inclusion of effective and accurate content in documents, and communicate significant GMP documentation changes in procedures to process owners
Skills & Experience Required:
Bachelor's degree in relevant field.Master's degree preferred.
Knowledge of cGMP, FDA and other regulatory requirements and quality systems.Working knowledge of SAP and MES eBR with demonstrated ability to learn other facets of SAP and MES (i.e. eSOP, eBR, eChecklist and change control). Proficient use of MS Office Suite, Visio, Arris, digital imaging.Practical experience in the biopharmaceutical industry is required given the highly regulated safety and quality standards.
Find out more about this role by reading the information below, then apply to be considered.Location: Marietta, PA 17547Job Type: Contract (3 M)
Job Description:
Promote a highly safety conscious culture and EHS focused workforce.Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice.
Job Responsibilities:
Serve as a Technical Writer dedicated to authoring, revising, and improving documents within manufacturing. (Business processes, SOPs, batch records, checklists, etc.)Serve as liaison between manufacturing groups, as well as between manufacturing and support departments, to ensure accurate, compliant, and streamlined controlled documentsDrive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documentsChampion standardization of documents across groups within manufacturing (e.g., content, structure, format, etc.)Serve as a change coordinator for projects in the manufacturing departmentPartner with learning and development as well as Manufacturing groups to ensure documents support accurate representation of operations and provide a foundation for education and competencyFormat and manage documents using appropriate guidelines and established document templatesEvaluate GMP documentation change requests to determine scope of change, and ensure accurate information in revision history (associated CAPAs, Change Controls, Impact Assessments, etc.)Where appropriate, manage CAPA tasks related to GMP documentation revisionsDetermine when GMP documentation duplications exist and manage resolution and consolidation of affected documentsSupport Lean/Six Sigma program to drive and embed a culture of continuous improvement by the use of operational excellence methodologies to realize ever-increasing levels of value in the usability and practicality of documentsPartner with LSOP Process Owners, to obtain accurate content for inclusion in documents, utilizing shop floor Gembas and process walk-downs, to drive inclusion of effective and accurate content in documents, and communicate significant GMP documentation changes in procedures to process owners
Skills & Experience Required:
Bachelor's degree in relevant field.Master's degree preferred.
Knowledge of cGMP, FDA and other regulatory requirements and quality systems.Working knowledge of SAP and MES eBR with demonstrated ability to learn other facets of SAP and MES (i.e. eSOP, eBR, eChecklist and change control). Proficient use of MS Office Suite, Visio, Arris, digital imaging.Practical experience in the biopharmaceutical industry is required given the highly regulated safety and quality standards.