What are the responsibilities and job description for the Document Control Coordinator position at Dental Technologies, Inc.?
Job Description
SUMMARY:
Under the direction of the Quality Assurance Manager, performs Document Control and Quality Assurance activities related to document management and compliance to Quality Standards per cGMP.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Coordinates the activities of Document Control, including distribution and auditing controlled documents to verify completeness and accuracy.
Manages maintenance and archival activities for controlled documents such as New Releases, Design Change Notices, Batch Records, etc.
Works with document originators in a collaborative manner to prepare, revise and resolve any controlled documents.
Ensures accurate and timely release of documents.
Reviews and proofreads documents to ensure consistency of approved format.
Issues production documents such as batch records, test forms, etc.
Issues batch records in accordance with MWI-215.
Generates and releases Certificate of Analysis and Certificate of Manufacture.
Coordinates internal audit activities with Management Representative.
Adheres to and enforces Company Policies and Procedures as they relate to Document Control.
The information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities and qualifications.
SUPERVISORY RESPONSIBILITIES: None.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Four year college degree
Experience with Quality System Documentation
Working knowledge of ISO, FDA, and cGMP concepts and guidelines. Prior experience in a Medical Device or other Quality Assurance related industry preferred.
REQUIRED SKILLS:
Able to read, analyze, and interpret professional journals, technical procedures, or governmental regulations.
Must demonstrate excellent verbal and written communication skills including grammar, punctuation, proofreading and spelling skills.
Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
Demonstrated ability to work accurately, follow instructions, schedules, and timelines and handle multiple priorities.
Self-motivated, well-organized, thorough and detailed oriented.
Ability to utilize word-processing, spreadsheet and database applications including MS Office applications (Word, Excel and Access).
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individual with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Company Description
Dental Technologies, Inc. is a company specializing in the research, formulation, compounding and packaging of dental, orthodontic and oral pharmaceutical products. Some products include dental restoratives, core build-ups, bonding agents, orthodontic adhesives, prophylaxis paste, fluoride treatments, toothpaste and varnishes. Dental Technologies maintains the ISO 13485:2016 quality system and employs more than 70 people, with research at the focus of our strategy. Dental Technologies, Inc. is dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. With process control experts committed to the highest level of integrity, quality, and service, Dental Technologies, Inc. ensures risk free product manufacturing - See more at: www.dentaltech.com/
Dental Technologies, Inc. is a company specializing in the research, formulation, compounding and packaging of dental, orthodontic and oral pharmaceutical products. Some products include dental restoratives, core build-ups, bonding agents, orthodontic adhesives, prophylaxis paste, fluoride treatments, toothpaste and varnishes. Dental Technologies maintains the ISO 13485:2016 quality system and employs more than 70 people, with research at the focus of our strategy. Dental Technologies, Inc. is dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. With process control experts committed to the highest level of integrity, quality, and service, Dental Technologies, Inc. ensures risk free product manufacturing - See more at: www.dentaltech.com/
SUMMARY:
Under the direction of the Quality Assurance Manager, performs Document Control and Quality Assurance activities related to document management and compliance to Quality Standards per cGMP.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Coordinates the activities of Document Control, including distribution and auditing controlled documents to verify completeness and accuracy.
Manages maintenance and archival activities for controlled documents such as New Releases, Design Change Notices, Batch Records, etc.
Works with document originators in a collaborative manner to prepare, revise and resolve any controlled documents.
Ensures accurate and timely release of documents.
Reviews and proofreads documents to ensure consistency of approved format.
Issues production documents such as batch records, test forms, etc.
Issues batch records in accordance with MWI-215.
Generates and releases Certificate of Analysis and Certificate of Manufacture.
Coordinates internal audit activities with Management Representative.
Adheres to and enforces Company Policies and Procedures as they relate to Document Control.
The information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities and qualifications.
SUPERVISORY RESPONSIBILITIES: None.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Four year college degree
Experience with Quality System Documentation
Working knowledge of ISO, FDA, and cGMP concepts and guidelines. Prior experience in a Medical Device or other Quality Assurance related industry preferred.
REQUIRED SKILLS:
Able to read, analyze, and interpret professional journals, technical procedures, or governmental regulations.
Must demonstrate excellent verbal and written communication skills including grammar, punctuation, proofreading and spelling skills.
Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
Demonstrated ability to work accurately, follow instructions, schedules, and timelines and handle multiple priorities.
Self-motivated, well-organized, thorough and detailed oriented.
Ability to utilize word-processing, spreadsheet and database applications including MS Office applications (Word, Excel and Access).
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individual with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Company Description
Dental Technologies, Inc. is a company specializing in the research, formulation, compounding and packaging of dental, orthodontic and oral pharmaceutical products. Some products include dental restoratives, core build-ups, bonding agents, orthodontic adhesives, prophylaxis paste, fluoride treatments, toothpaste and varnishes. Dental Technologies maintains the ISO 13485:2016 quality system and employs more than 70 people, with research at the focus of our strategy. Dental Technologies, Inc. is dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. With process control experts committed to the highest level of integrity, quality, and service, Dental Technologies, Inc. ensures risk free product manufacturing - See more at: www.dentaltech.com/
Dental Technologies, Inc. is a company specializing in the research, formulation, compounding and packaging of dental, orthodontic and oral pharmaceutical products. Some products include dental restoratives, core build-ups, bonding agents, orthodontic adhesives, prophylaxis paste, fluoride treatments, toothpaste and varnishes. Dental Technologies maintains the ISO 13485:2016 quality system and employs more than 70 people, with research at the focus of our strategy. Dental Technologies, Inc. is dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. With process control experts committed to the highest level of integrity, quality, and service, Dental Technologies, Inc. ensures risk free product manufacturing - See more at: www.dentaltech.com/