US
0 suggestions are available, use up and down arrow to navigate them
You’re being taken to an external site to apply.
Enter your email below to receive job recommendations for similar positions.
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.
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.
Recommended Skills
- Information Technology
- Software Development
- Data Analysis
- Systems Design
- Systems Analysis
- Business Requirements
Help us improve CareerBuilder by providing feedback about this job:
Job ID: MjIyMjoyMy0wNzc3My05MDc
CareerBuilder TIP
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.