Job Title: Sr. Quality Assurance Consultant
Job Description
Acts as a Subject Matter Expert on applicable standards and regulations for the organization.
Drives inspection readiness and improvement to regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites.
Provides corporate training on inspection readiness, inspection process, and best practices.
Conducts internal audits to ensure a constant state of compliance.
Plans and executes compliance audits of internal operations to ensure compliance with policies, procedures, and regulatory requirements; drives timely completion of associated corrective actions.
Tracks and trends multi-site compliance issues to assure alignment with corporate standards.
Manages the Compliance Surveillance program, tracking and trending new and changed regulations, agency guidance documents, industry standards, etc., identifying impact to the organization and driving resolution to close gaps.
Responds in a timely manner to compliance concerns and contributes to problem resolution.
Trends audit/inspection findings and observations.
Communicates results expediently to leadership and applicable groups.
Supports and may lead quality and process improvements aimed at addressing compliance gaps and continuous improvement; supporting a LEAN company culture.
Hard Skills
* Quality Assurance
* Audit
* Compliance
* Quality Management Review
* CAPA
* Internal Audit
* External Audit
* Auditing
Job Type
This is a contract position with a duration of 6 Month(s).
Work Site
This is a fully on-site position in North Billerica, Massachusetts.
Work Environment
They will be working within the quality team and on the compliance QA team.
They will be reporting to the Executive Director who oversees document management, strategic quality, and compliance.
They will be working very closely with 2 other individuals.
They will be working onsite 4 days a week with one day from home being flexible.
If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions.
We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people.
DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ****** for other accommodation options.