Wave Life Sciences
Quality Assurance Specialist III, QA Training
Wave Life Sciences, Lexington, Massachusetts, United States, 02173
Quality Assurance Specialist III, QA Training
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Quality Assurance Specialist III, QA Training
role at
Wave Life Sciences .
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha‑1 antitrypsin deficiency, Huntington’s disease, obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible,” we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description As a member of Wave’s Quality Assurance (QA) team, the Quality Assurance Specialist III, QA Training will be responsible for the oversight and maintenance of Wave’s GxP Training program. This role partners with functional leaders to develop and maintain effective training that promotes employee competency and compliance readiness. This is an in‑person role onsite at our Lexington facility requiring a minimum of 4 days onsite.
Experience
Bachelor’s degree with a minimum of 4 years of related or transferable experience in the pharmaceutical or biotechnology industry, preferably in Quality Assurance/Training
Experience in the administration of electronic learning management systems (Veeva and/or ComplianceWire preferred)
Experience in training program administration
Experience working in a GMP manufacturing facility
Responsibilities
Manage the training program
Creation and revision of role‑based training curricula to align with functional responsibilities
Manage onboarding of new employees by facilitating Quality onboarding training, verifying account creation and assigning curricula in Wave’s Learning Management System
Support the creation and revision of Training related SOPs, work instructions, and training materials in collaboration with Subject Matter Experts (SMEs)
Provide training and support for employees on the use of the Learning Management System (LMS)
Support the development of training materials such as quizzes, instructor‑led courses, and on‑the‑job training
Facilitate GxP training for employees, as needed
Oversight of training compliance across all departments, publish periodic training reports, and elevate compliance issues to management
Collaborate cross‑functionally to support LMS upgrades, vendor releases, and change management
Manage or support the timely closure of relevant Quality System records
Identify and participate in initiatives to improve the training program, LMS and training content
Support development of Quality Management Review content to measure the health and effectiveness of the training program
Support audits and regulatory authority inspections by providing training reports/documentation or other assigned tasks
Oversight and timely response of training related inquiries
Other duties as assigned
Ensure timely completion of annual training review by providing support to functional leads and escalating issues to management
Oversight of employees’ CVs and job descriptions to ensure compliance
Ensure timely generation and review of content for Annual GMP refresher training
Key Skills
Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance
Superior organization skills with ability to manage competing priorities and meet deadlines
Demonstrated ability to train GxP personnel one‑on‑one and in groups
Works independently with minimal supervision
Excellent team player with strong written and verbal communication skills
Ability to work cross‑functionally while providing excellent customer service
Knowledge of instructional design principles for adult learning
Champions continuous process improvement
Proficient with MS Office Suite including Word, Excel and PowerPoint
Pay Range The annual base salary range for this position is $102,000 – $138,000.
This range is an estimate. Actual annual base salary will vary based on several factors including relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock‑based long‑term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees and their families’ physical and financial health and overall well‑being.
EEO Statement Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation and training.
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.
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Quality Assurance Specialist III, QA Training
role at
Wave Life Sciences .
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha‑1 antitrypsin deficiency, Huntington’s disease, obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible,” we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description As a member of Wave’s Quality Assurance (QA) team, the Quality Assurance Specialist III, QA Training will be responsible for the oversight and maintenance of Wave’s GxP Training program. This role partners with functional leaders to develop and maintain effective training that promotes employee competency and compliance readiness. This is an in‑person role onsite at our Lexington facility requiring a minimum of 4 days onsite.
Experience
Bachelor’s degree with a minimum of 4 years of related or transferable experience in the pharmaceutical or biotechnology industry, preferably in Quality Assurance/Training
Experience in the administration of electronic learning management systems (Veeva and/or ComplianceWire preferred)
Experience in training program administration
Experience working in a GMP manufacturing facility
Responsibilities
Manage the training program
Creation and revision of role‑based training curricula to align with functional responsibilities
Manage onboarding of new employees by facilitating Quality onboarding training, verifying account creation and assigning curricula in Wave’s Learning Management System
Support the creation and revision of Training related SOPs, work instructions, and training materials in collaboration with Subject Matter Experts (SMEs)
Provide training and support for employees on the use of the Learning Management System (LMS)
Support the development of training materials such as quizzes, instructor‑led courses, and on‑the‑job training
Facilitate GxP training for employees, as needed
Oversight of training compliance across all departments, publish periodic training reports, and elevate compliance issues to management
Collaborate cross‑functionally to support LMS upgrades, vendor releases, and change management
Manage or support the timely closure of relevant Quality System records
Identify and participate in initiatives to improve the training program, LMS and training content
Support development of Quality Management Review content to measure the health and effectiveness of the training program
Support audits and regulatory authority inspections by providing training reports/documentation or other assigned tasks
Oversight and timely response of training related inquiries
Other duties as assigned
Ensure timely completion of annual training review by providing support to functional leads and escalating issues to management
Oversight of employees’ CVs and job descriptions to ensure compliance
Ensure timely generation and review of content for Annual GMP refresher training
Key Skills
Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance
Superior organization skills with ability to manage competing priorities and meet deadlines
Demonstrated ability to train GxP personnel one‑on‑one and in groups
Works independently with minimal supervision
Excellent team player with strong written and verbal communication skills
Ability to work cross‑functionally while providing excellent customer service
Knowledge of instructional design principles for adult learning
Champions continuous process improvement
Proficient with MS Office Suite including Word, Excel and PowerPoint
Pay Range The annual base salary range for this position is $102,000 – $138,000.
This range is an estimate. Actual annual base salary will vary based on several factors including relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock‑based long‑term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees and their families’ physical and financial health and overall well‑being.
EEO Statement Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation and training.
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.
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