Hybrid Min 3 Days onsite.
Candidate must be local or willing to relocate to the area (at their own expense)
Free Parking onsite
Title: Sr. QS Specialist
The position will walk the floor and support audit efforts for Quality Team
Must Have:
• Minimum 7 years in Quality Roles (Pharmaceutical)
• Risk Management, Deviations, CAPA’s, Change Controls
• Inspection of Materials Experience
• Internal/ External Audits
Nice to Have:
• 7-9 Years of experience in Quality Roles (Pharmaceutical)
Job Description
• Supports as a lead resource with perform/improvement of Client’s mRNA CoE Risk Management Program.
• Support as a lead resource for improvement of Client’s mRNA CoE Inspection Readiness Program.
Support with Internal and External audit:
• Assist with planning audit calendars, developing audit schedules, and maintaining audit logs.
• Support communicating with external vendors, creating schedule and provide necessary support for timely project deliverables.
• Help with scheduling, planning, execution, and documentation of internal audits of Client’s mRNA CoE QMS.
• Provide support to close all audit findings in a timely manner with effective corrective action, by assisting owners on investigations and action plans.
• Assist the Vendor Management Program, which includes the vendor and qualification process.
• Support with creating new vendor request forms and vendor evaluations.
• Help communicating with external vendors for creation and response to vendor questionnaires.
• Support writes, review, and negotiation of Quality Agreements with Vendors.
• Support with initiating/closure of Change Control, CAPA and Deviation in Client’s mRNA CoE QMS and according to procedure.
• Help writes, review, and approve Standard Operating Procedures (SOP) and Forms for the organization.
• 6-9 years total experience
• Bachelor’s 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.
About Rangam: Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries. Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.
