To begin the application process, please enter your email address.
Company Contact Info
- Saint Petersburg, FL
Sorry, we cannot save or unsave this job right now.
Report this Job
Saving Your Job Alert
Job Alert Saved!
Could not save Job Alert!
You have too many Job Alerts!
This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.
Email Send Failed!
Experis • Saint Petersburg, FL
Posted 11 days ago
*Responsible for review/approval of technical documents including change controls, material/product specifications, test methods, product process validation and cleaning validation documents.
*Responsible for ensuring the site is in compliance with cGMP guidelines, adherence to Quality Policies and Standards.
*Partners with other functional areas to ensure compliance for the site.
*Will provide directional support and leadership to drive actions and enhancements to the QMS.
*Ensure Quality systems are compliant with corporate procedures, regulatory requirements and industry standards for systems such Deviation investigations, Batch record review, Equipment/Facilities, root cause analysis, CAPAs, Drive continuous improvement initiatives.
*Oversees Deviation investigation system to ensure timely closure of deviations, corrective actions, and effectiveness checks.
*Ensures investigation teams conduct thorough root cause analysis, identifies and implements corrective and preventive action plans to eliminate repeat observations and reviews/approves deviation investigations.
*Manages team routinely engaging in client interactions and client audits and participates in those activities as needed.
*Manages team responsible for performing batch record review and disposition activities for commercial and clinical trial batches.
*Works on complex issues where analysis requires an in-depth knowledge of the manufacturing processes and corporate goals.
*Participate in Regulatory Inspections. Author and maintain detailed SOPs defining site Quality Systems.
*Author/compile monthly, quarterly and annual summaries and metrics.
*Present summary data to site management on a regularly scheduled basis. Liaison for clients and internal customers.
*Direct reports manage daily client interactions.
*Is expected to become the escalation point for client requests/issues.
*Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.
*Coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, corrections, and effectiveness checks. Review quality metrics, trackers, and reports to characterize the health of the client relationship and state of quality systems.
*Provide QA Technical recommendations based on trend analysis to eliminate future problems.
*Participates in R&D/Technical Services/Validation/Engineering project meetings to provide QA input with respect to compliance to cGMP requirements.
*Reviews and approves technical documents, such as Technical Services Protocols and Reports; Process Validation Protocols and Reports; Cleaning Validation Protocols and Reports; Protocols and Reports; Material and Product specifications; Test methods; Master Batch Records; and Master Shipper Labels.
*Change Control, as it pertains to the above validated/qualified systems and controlled documents.
*Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.
*BS in Science.
*5+yrs QA experience.
*Contract manufacturing and validation/technical services preferred.
*Knowledge of cGMPs and OSHA regulations required.
*Certified Quality Engineer a plus.
Experis is an Equal Opportunity Employer (EOE/AA)