We are seeking a Senior Quality Records Specialist to join our Manufacturing Technical Operations (MTO) team in Boston. This role involves complete ownership of quality records, including Deviations, CAPAs, Change Controls, Risk Assessments, and Analytical and Quality Control Investigations supporting cell manufacturing.
Key Responsibilities:
-Triage manufacturing issues in real-time on the manufacturing floor.
-Lead and write investigations for quality events using root cause analysis tools.
-Collaborate with SMEs to determine immediate actions, containment, and document impact assessments.
-Propose corrective and preventive actions based on root cause analysis.
-Manage CMC CAPAs and change controls from initiation to closure.
-Own deviations, CAPA, Effectiveness Check (EC), and Risk Assessment records in eQMS.
-Ensure all timelines and due dates are met.
Promote compliance best practices within MTO and QA teams.
-Support MTO intake and prioritization, distributing and acting on metrics.
-Implement MTO best practices and ensure exceptional collaboration and communication.
-Maintain schedule flexibility to support cell manufacturing clinical hours.
-Perform other duties and projects as assigned.
-This is an on-site position based in Boston. If you are passionate about quality and compliance in cell manufacturing, we encourage you to apply.
-SHIFTS:
- Sun-Wed 12-10:30p
Compensation:
$50/hr to $65/hr.
Exact compensation may vary based on several factors, including skills, experience, and education.
Employees in this role will enjoy a comprehensive benefits package starting on day one of
employment, including options for medical, dental, and vision insurance. Eligibility to enroll in
the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this
role will have access to paid sick leave and other paid time off benefits as required under the
applicable law of the worksite location.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
Human Resources Request Form. The EEOC "Know Your Rights" Poster is available
here.
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https://insightglobal.com/workforce-privacy-policy/ .
6+ years progressive experience in pharmaceutical development and manufacturing.
BS in engineering, science or related discipline.
Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
Experienced with technical writing and performing event investigations in a GMP-compliant environment.
Experience gowning manufacturing floor in Grade B environments.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.