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Sr. QS Specialist at Integrated Resources, Inc

Sr. QS Specialist

Integrated Resources, Inc Waltham, MA (Onsite) Full-Time
*Hybrid Min 3 Days onsite
Title: Sr. QS Specialist

Job Description
1. Supports as a lead resource with perform/improvement of Clients mRNA CoE Risk Management Program.
2. Support as a lead resource for improvement of Clients mRNA CoE Inspection Readiness Program.
3. Support with Internal and External audit:
a. Assist with planning audit calendars, developing audit schedules, and maintaining audit logs.
b. Support communicating with external vendors, creating schedule and provide necessary support for timely project deliverables.
c. Help with scheduling, planning, execution, and documentation of internal audits of Clients mRNA CoE QMS.
d. Provide support to close all audit findings in a timely manner with effective corrective action, by assisting owners on investigations and action plans.
4. Assist the Vendor Management Program, which includes the vendor approval and qualification process.
a. Support with creating new vendor request forms and vendor evaluations.
b. Help communicating with external vendors for creation and response to vendor questionnaires.
c. Support writes, review, and negotiation of Quality Agreements with Vendors.
5. Support with initiating/closure of Change Control, CAPA and Deviation in Clients mRNA CoE QMS and according to procedure.
6. Help writes, review, and approve Standard Operating Procedures (SOP) and Forms for the organization.
6-9 years total experience
Bachelors Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other
technical/scientific area
Pharmaceutical/biotechnology industry experience (7+ years) with at least 5 years in a
Quality function.

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