Theragenics
POSITION SUMMARY:
The Documentation Specialist is responsible for overseeing the daily activities of Document Control, adherence to specifications/ quality procedures and meeting strict quality and compliance standards. This position is also responsible for maintaining the Document Control System in compliance to ISO/QSR, CGMP requirements and approved procedures. This position will update master documents to reflect approved changes, update master indexes and files, distribution of updated documents, obsolescing/ archiving old revisions, as well as creation, filing, of batch records.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Assist in the hiring, training or coordinate the training of document control personnel. Schedule and coordinate the work of document control personnel under the direction of the regulatory Quality Engineer Develop document control procedures and analyze and present data for management. Provide input on performance reviews for the document control personnel. Oversee document change order process, ensuring ECN's are processed in compliance to written procedures. Issue batch record documents and file/archive completed batch records. Prepare key indicator charts of performance goals, actual results and trend analyses for document control processes. Provide a guidance role to R&D, Engineering, and Manufacturing personnel for the development of all new product documentation being transferred from Development into Operations. Provide suggestions on improvement of Quality procedures without sacrificing efficiency or compliance to regulatory requirements POSITION REQUIREMENTS:
EDUCATION:
High School Diploma with a minimum 1-3 years related experience in QA documentation, technical writing, or equivalent combination of education, training, and experience. Bachelors of Science Degree Preferred EXPERIENCE:
Previous experience in Quality in a regulated industry, 1-3 years specifically in a medical device environment. KNOWLEDGE/SKILLS/ABILITIES:
Familiar with QSR/ISO regulations and/or proven ability to work in a regulated environment according to written procedures. Excellent verbal and written communication skills. Must work independently and be able to prioritize numerous duties. Proven ability to use MS Word, Excel, and databases in order to facilitate a satisfactory documentation program. Must be able to get along well with all levels of employees. Must work quickly and efficiently with detail and accuracy Ability to maintain a professional manner and appearance. Must be organized and detail oriented. WORK ENVIRONMENT:
Working conditions are normal for an office environment. Work requires occasional standing, sitting, walking, typing, talking, hearing, close and distance reading as well as the ability to lift/move documents.
The Documentation Specialist is responsible for overseeing the daily activities of Document Control, adherence to specifications/ quality procedures and meeting strict quality and compliance standards. This position is also responsible for maintaining the Document Control System in compliance to ISO/QSR, CGMP requirements and approved procedures. This position will update master documents to reflect approved changes, update master indexes and files, distribution of updated documents, obsolescing/ archiving old revisions, as well as creation, filing, of batch records.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Assist in the hiring, training or coordinate the training of document control personnel. Schedule and coordinate the work of document control personnel under the direction of the regulatory Quality Engineer Develop document control procedures and analyze and present data for management. Provide input on performance reviews for the document control personnel. Oversee document change order process, ensuring ECN's are processed in compliance to written procedures. Issue batch record documents and file/archive completed batch records. Prepare key indicator charts of performance goals, actual results and trend analyses for document control processes. Provide a guidance role to R&D, Engineering, and Manufacturing personnel for the development of all new product documentation being transferred from Development into Operations. Provide suggestions on improvement of Quality procedures without sacrificing efficiency or compliance to regulatory requirements POSITION REQUIREMENTS:
EDUCATION:
High School Diploma with a minimum 1-3 years related experience in QA documentation, technical writing, or equivalent combination of education, training, and experience. Bachelors of Science Degree Preferred EXPERIENCE:
Previous experience in Quality in a regulated industry, 1-3 years specifically in a medical device environment. KNOWLEDGE/SKILLS/ABILITIES:
Familiar with QSR/ISO regulations and/or proven ability to work in a regulated environment according to written procedures. Excellent verbal and written communication skills. Must work independently and be able to prioritize numerous duties. Proven ability to use MS Word, Excel, and databases in order to facilitate a satisfactory documentation program. Must be able to get along well with all levels of employees. Must work quickly and efficiently with detail and accuracy Ability to maintain a professional manner and appearance. Must be organized and detail oriented. WORK ENVIRONMENT:
Working conditions are normal for an office environment. Work requires occasional standing, sitting, walking, typing, talking, hearing, close and distance reading as well as the ability to lift/move documents.