Sr Quality Specialist

About the company:
Validated Cloud is the #1 Community Cloud for Life Science Regulated Systems. The team at Validated Cloud owns, manages and maintains a cloud infrastructure designed to meet the regulatory requirements in the US and EU. Validated Cloud enables compliant systems and provides an extremely high level of support for our customer's critical data.
Who we are looking for?
The ideal candidate is meticulous and uses industry guidelines to measure twice and cut once. You know and understand how critical all of the details are to ensuring compliance from Good Documentation Practices, Quality System Implementation, Data Integrity, married with IT best practices. You appreciate the importance of paperwork and organization that comprises Quality Assurance coupled with team collaboration and the occasional customer interaction.
A day in the life:
The role of the Senior Quality Specialist is to review and approve validation documentation generated for the Validated Cloud environment. This includes executed protocols, scripts, deviations, incidents, change controls, and system design specifications. This role may also include filing, scanning, and overall documentation organization. This role includes providing quality system guidance/training to the engineering staff to ensure compliance to GxP standard and processes. This role is senior-level and will be onsite in Waltham, MA.
Required skills and qualifications:
-Attention to detail - Some may call you a perfectionist
-Highly motivated - Driven to succeed and grow
-Multitasking and work prioritization with a high degree of independence
-Articulate written and oral communication - You know how to effectively deliver a message
-Team and customer collaboration - You want your colleagues and customers to be happy and successful too
-Prior experience at pharma or biotech company in a QA role for at least 4+ years.
-Hands on experience and strong understanding of industry regulations and how to apply them including HIPAA, GDPR, 21 CFR Part 820, 21CFR Part 11, Annex 11, ISO 27001, and GxP
-Hands on experience with CAPA, Change Control (including emergency changes), Deviation, incidents, and validation documentation (IQ/OQ/PQ).
-Microsoft Office 365/Windows proficient
-Experience with audits and defending company policies and procedures is a plus
-A bachelor's degree is preferred, but not required

What we have to offer:
A relaxed company culture which values work life balance. We work to live, value family and our time away from the office. Validated Cloud offers amazing benefits at no cost to you. Limitless potential to grow and learn valuable regulatory, validation, and quality assurance skills.
Employment Type: Full-Time
Salary: $ 90,000.00 Per Year