Regulatory and Quality Assurance Specialist II (Remote)
US Fertility, the nation’s largest partnership of physician-owned and physician-led top-tier fertility practices, a national network of premier IVF laboratories, are united under a shared mission to deliver the joy of parenthood through advanced reproductive medicine and innovative science.
The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA, State, Local and AABB).
We have an immediate opening for a full-time Regulatory and Quality Assurance Special II to join our team. The schedule for this position is Monday-Friday 9am-5pm, and requires travel to Marlborough, MA once per month or as needed.
How You'll Contribute:
• Implement, monitor, maintain, and improve the company’s Quality System
• Implement, monitor, and maintain a document control system
• Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed
• Assure appropriate licensure is held and maintained by the company
• Facilitate quarterly meetings with medical directors to provide regulatory and quality updates
• Ensure medical directors complete all signoffs as required
• Assure compliance to international regulatory agencies
• Tracking and trending of laboratory, cryogenic, andrology, and deviation systems
• Maintain and improve deviation/non-conformance system
• Report events to regulatory bodies as applicable
• Assure training and competency of all staff
• Assist in preparation of regulatory strategies for changes to existing systems
• Participate in Continuing Education programs in related field
• Participate in planning and implementation of regulatory systems, document/change control and validation activities
• Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies
• Implement and oversee audits for departments and systems to assure compliance to regulations and standards
• Track and ensure any identified deficiencies are rectified post an inspection/audit event
• Monthly and quarterly in person audits of quality and regulatory manuals and records
• Monthly and quarterly reports to leadership on Quality and Regulatory activities
• Perform other related duties as assigned by management
What You'll Bring:
• Bachelor’s degree or equivalent combination of training and experience
• Must have a high level of interpersonal skills to handle sensitive and confidential situations. Position continually requires demonstrated poise, tact, and diplomacy
• Must be able to interact and communicate professionally with individuals at all levels of the organization
• Clear and effective communication skills
• Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint)
• Self-starter that adapts well to change in a fast-paced, dynamic environment
• Prior laboratory experience preferred
• Knowledge of industry, Federal and State regulations, licensing processes
• Strong aptitude for analyzing data, audit processes and reconciling records
• Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes
• Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships.
• Excellent verbal & written communication skills
• Ability to work as part of a multi-disciplinary team
• Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.)
• Occasional travel required (up to 25%)
• Able to adapt and thrive in the fast-paced, rapidly changing environment
• The successful candidate will have the ability to work well independently, as well as part of a team
• Excellent multi-tasking abilities
More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful.
What We Offer:
• Competitive pay + bonus
• Comprehensive training
• Medical, dental, vision, and 401(k) matching
• Generous paid time off and holidays
• Retirement plan
• Tuition assistance
• Ability to make an impact in the communities we serve
At US Fertility, we promote and develop individual strengths in order to help staff grow personally and professionally. This is an ideal time to join our team!
To learn more about our company and culture, visit here.
Apply tot his job
Apply To this Job
The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA, State, Local and AABB).
We have an immediate opening for a full-time Regulatory and Quality Assurance Special II to join our team. The schedule for this position is Monday-Friday 9am-5pm, and requires travel to Marlborough, MA once per month or as needed.
How You'll Contribute:
• Implement, monitor, maintain, and improve the company’s Quality System
• Implement, monitor, and maintain a document control system
• Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed
• Assure appropriate licensure is held and maintained by the company
• Facilitate quarterly meetings with medical directors to provide regulatory and quality updates
• Ensure medical directors complete all signoffs as required
• Assure compliance to international regulatory agencies
• Tracking and trending of laboratory, cryogenic, andrology, and deviation systems
• Maintain and improve deviation/non-conformance system
• Report events to regulatory bodies as applicable
• Assure training and competency of all staff
• Assist in preparation of regulatory strategies for changes to existing systems
• Participate in Continuing Education programs in related field
• Participate in planning and implementation of regulatory systems, document/change control and validation activities
• Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies
• Implement and oversee audits for departments and systems to assure compliance to regulations and standards
• Track and ensure any identified deficiencies are rectified post an inspection/audit event
• Monthly and quarterly in person audits of quality and regulatory manuals and records
• Monthly and quarterly reports to leadership on Quality and Regulatory activities
• Perform other related duties as assigned by management
What You'll Bring:
• Bachelor’s degree or equivalent combination of training and experience
• Must have a high level of interpersonal skills to handle sensitive and confidential situations. Position continually requires demonstrated poise, tact, and diplomacy
• Must be able to interact and communicate professionally with individuals at all levels of the organization
• Clear and effective communication skills
• Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint)
• Self-starter that adapts well to change in a fast-paced, dynamic environment
• Prior laboratory experience preferred
• Knowledge of industry, Federal and State regulations, licensing processes
• Strong aptitude for analyzing data, audit processes and reconciling records
• Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes
• Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships.
• Excellent verbal & written communication skills
• Ability to work as part of a multi-disciplinary team
• Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.)
• Occasional travel required (up to 25%)
• Able to adapt and thrive in the fast-paced, rapidly changing environment
• The successful candidate will have the ability to work well independently, as well as part of a team
• Excellent multi-tasking abilities
More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful.
What We Offer:
• Competitive pay + bonus
• Comprehensive training
• Medical, dental, vision, and 401(k) matching
• Generous paid time off and holidays
• Retirement plan
• Tuition assistance
• Ability to make an impact in the communities we serve
At US Fertility, we promote and develop individual strengths in order to help staff grow personally and professionally. This is an ideal time to join our team!
To learn more about our company and culture, visit here.
Apply tot his job
Apply To this Job