FUJIFILM Biosciences
Position Description
We are hiring a
Document Control Manager . The Document Control Manager will manage Document Control personnel and related systems. They will provide guidance and supervision of Document Control functions, which include the creation, revision, approval, maintenance and issuing/printing of product labels, SOPs, posters, forms and other controlled documents. They will also manage training recording and comprehension verification and be in charge of the development, maintenance and implementation of electronic document management system improvements and revisions. Company Overview
At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the worlds biggest health challenges. Job Description
Responsibilities Manage System for controlled documents, training and label control. Develop, execute and report on assigned Document Control objectives. Provide work direction, measurements of results to assigned personnel: Production of labels for manufacturing, including assuring that label masters are revised and approved, that label inventory is accurate and monitored Coordination of product inserts creation, translations, issuance, printing and inventory maintenance of the most current revisions. Identification, qualification and coordination of new label or printing suppliers (as per as needed basis).
Assist with creation and revisions of Raw Material Specifications and Inspection Reports. Make recommendations for the improvement of internal procedures regarding efficiency, cost reduction and improved Document Control programs. Assist and support Regulatory Affairs department during the submission of regulatory files with by providing related technical documents. Assist and support the QA Auditing department during audits, by providing technical documents and support needed. Manage Electronic QMS software (MasterControl).
Required Skills/Education
Bachelors degree required A minimum of five (5) years of Quality Assurance and or Document Control in a medical device manufacturer or equivalent. A minimum of four (4) years of supervisory or management experience preferred. Experience with MS Office applications/software Overall knowledge of Adobe InDesign, Photoshop, and Illustrator software preferred Experience implementing, maintaining, updating, improving eQMS software MasterControl preferred Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDAs GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide. Current industry FDA regulations, i.e. cGMP, 21 CFR 820, ISO 13485, Canadian Medical Device Regulations, Code of Federal Regulations, Excel, Novell, Windows 2000 or similar. Knowledge of Quality Assurance Document Control Systems. Ability to speak, write and read English fluently Good oral and written communication skills.
Salary And Benefits
For California, the base salary range for this position is $103,093 - $134,204 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.). Medical, Dental, Vision Life Insurance 401k Paid Time Off
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com). Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Administrative
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We are hiring a
Document Control Manager . The Document Control Manager will manage Document Control personnel and related systems. They will provide guidance and supervision of Document Control functions, which include the creation, revision, approval, maintenance and issuing/printing of product labels, SOPs, posters, forms and other controlled documents. They will also manage training recording and comprehension verification and be in charge of the development, maintenance and implementation of electronic document management system improvements and revisions. Company Overview
At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the worlds biggest health challenges. Job Description
Responsibilities Manage System for controlled documents, training and label control. Develop, execute and report on assigned Document Control objectives. Provide work direction, measurements of results to assigned personnel: Production of labels for manufacturing, including assuring that label masters are revised and approved, that label inventory is accurate and monitored Coordination of product inserts creation, translations, issuance, printing and inventory maintenance of the most current revisions. Identification, qualification and coordination of new label or printing suppliers (as per as needed basis).
Assist with creation and revisions of Raw Material Specifications and Inspection Reports. Make recommendations for the improvement of internal procedures regarding efficiency, cost reduction and improved Document Control programs. Assist and support Regulatory Affairs department during the submission of regulatory files with by providing related technical documents. Assist and support the QA Auditing department during audits, by providing technical documents and support needed. Manage Electronic QMS software (MasterControl).
Required Skills/Education
Bachelors degree required A minimum of five (5) years of Quality Assurance and or Document Control in a medical device manufacturer or equivalent. A minimum of four (4) years of supervisory or management experience preferred. Experience with MS Office applications/software Overall knowledge of Adobe InDesign, Photoshop, and Illustrator software preferred Experience implementing, maintaining, updating, improving eQMS software MasterControl preferred Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDAs GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide. Current industry FDA regulations, i.e. cGMP, 21 CFR 820, ISO 13485, Canadian Medical Device Regulations, Code of Federal Regulations, Excel, Novell, Windows 2000 or similar. Knowledge of Quality Assurance Document Control Systems. Ability to speak, write and read English fluently Good oral and written communication skills.
Salary And Benefits
For California, the base salary range for this position is $103,093 - $134,204 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.). Medical, Dental, Vision Life Insurance 401k Paid Time Off
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com). Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Administrative
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