Manager, Quality Assurance, QMS Programs
Apply NowCompany: Asterand, Inc.
Location: Baltimore, MD 21215
Description:
SUMMARY
The Quality Manager, QMS Programs is the Quality Professional and MasterControl SME who is responsible for overseeing the management of MasterControl (the eQMS) including but not limited to the training and process associated modules within the electronic Quality Management System. This role reports directly to the Vice President of Global Quality.
REQUIRED: This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (USP, ISO 9001, USDA regulations) where site appropriate
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Work with business units and liaison with Master Control, as needed to solicit requirements for new modules, coordinate implementation and training, etc.
Account Development:
Creating all new user accounts.
Resetting e-signature passwords for all requirements.
Archiving user accounts for people who have left the company and coordinating with business unit leaders to transfer open tasks.
Integrations Management:
Working as the Training SME to ensure training compliance and train all new users on how to navigate and sign-off training AND also prepare training programs for other roles or users as required (i.e., DocControl role for those new to the role, how to create training programs/exams in MasterControl, etc.)
Implementation of MasterControl and all modules at new sites
Assisting with issues and act as the go to person for anyone's questions about MasterControl.
Reviews existing training programs; suggests enhancements and modifications to improve engagement, learning, and retention and/or to meet the changing needs of clientele, the organization, or the industry.
Ensures that training materials and programs are current, accurate, and effective.
Maintains knowledge of new methods and techniques for training, and training requirements applicable to the organization and/or industry.
Data Architect:
Creation of new modules and workflows within Master Control
Management of Change Control for MasterControl Validation
Collaborate with MasterControl architects and SMEs
Troubleshoot existing integrations and provide technical guidance and generate documentation for solutions (i.e. Work instructions, SOPs)
Perform miscellaneous tasks or other duties as assigned by manager and supported by training, education or experience.
TRAVEL
This position may require up to 10% travel over the course of a year.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and/or Experience
Bachelor degree in a related scientific field with 4-6 years relevant experience or equivalent combination of education and experience.
Minimum 5 years managing and dealing electronic QMS such as MasterControl. Familiarity with GMP, GLP or other related QA compliance systems.
Other Skills and Abilities
Thorough understanding of Master Control.
Understanding of quality system and business processes.
Understanding of Training Compliance Within a Regulated Business
Very strong computer skills essential to include proficiency with word processing (Microsoft Word) and databases (Access and Excel). Advanced skills or additional proficiency with quality management software systems preferable.
Must be organized, show attention to detail and demonstrate good documentation practices.
Solid communication skills, both written and oral, and good writing and editing skills.
Exceptional teamwork and leadership skills
Proficiency in MasterControl is preferred but not required.
PHYSICAL DEMANDS
REQUIRED: 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 individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to: Prolonged periods of sitting at a desk and working on a computer. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
This position is considered Administrative.
REQUIRED: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
While performing the duties of this job, the employee will be working in professional office environment using standard office equipment.
REQUIRED The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.
The Quality Manager, QMS Programs is the Quality Professional and MasterControl SME who is responsible for overseeing the management of MasterControl (the eQMS) including but not limited to the training and process associated modules within the electronic Quality Management System. This role reports directly to the Vice President of Global Quality.
REQUIRED: This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (USP, ISO 9001, USDA regulations) where site appropriate
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Work with business units and liaison with Master Control, as needed to solicit requirements for new modules, coordinate implementation and training, etc.
Account Development:
Creating all new user accounts.
Resetting e-signature passwords for all requirements.
Archiving user accounts for people who have left the company and coordinating with business unit leaders to transfer open tasks.
Integrations Management:
Working as the Training SME to ensure training compliance and train all new users on how to navigate and sign-off training AND also prepare training programs for other roles or users as required (i.e., DocControl role for those new to the role, how to create training programs/exams in MasterControl, etc.)
Implementation of MasterControl and all modules at new sites
Assisting with issues and act as the go to person for anyone's questions about MasterControl.
Reviews existing training programs; suggests enhancements and modifications to improve engagement, learning, and retention and/or to meet the changing needs of clientele, the organization, or the industry.
Ensures that training materials and programs are current, accurate, and effective.
Maintains knowledge of new methods and techniques for training, and training requirements applicable to the organization and/or industry.
Data Architect:
Creation of new modules and workflows within Master Control
Management of Change Control for MasterControl Validation
Collaborate with MasterControl architects and SMEs
Troubleshoot existing integrations and provide technical guidance and generate documentation for solutions (i.e. Work instructions, SOPs)
Perform miscellaneous tasks or other duties as assigned by manager and supported by training, education or experience.
TRAVEL
This position may require up to 10% travel over the course of a year.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and/or Experience
Bachelor degree in a related scientific field with 4-6 years relevant experience or equivalent combination of education and experience.
Minimum 5 years managing and dealing electronic QMS such as MasterControl. Familiarity with GMP, GLP or other related QA compliance systems.
Other Skills and Abilities
Thorough understanding of Master Control.
Understanding of quality system and business processes.
Understanding of Training Compliance Within a Regulated Business
Very strong computer skills essential to include proficiency with word processing (Microsoft Word) and databases (Access and Excel). Advanced skills or additional proficiency with quality management software systems preferable.
Must be organized, show attention to detail and demonstrate good documentation practices.
Solid communication skills, both written and oral, and good writing and editing skills.
Exceptional teamwork and leadership skills
Proficiency in MasterControl is preferred but not required.
PHYSICAL DEMANDS
REQUIRED: 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 individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to: Prolonged periods of sitting at a desk and working on a computer. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
This position is considered Administrative.
REQUIRED: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
While performing the duties of this job, the employee will be working in professional office environment using standard office equipment.
REQUIRED The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.