Randstad Investigator in Research Triangle Park, North Carolina
location:Research Triangle Park, NC
salary:$44 - $48 per hour
date posted:Thursday, December 6, 2018
industry:Professional, Scientific, and Technical Services
Are you the one that likes to ensure quality and safety in the work environment? Do you live in or near the heart of RTP? Randstad has a premier client looking for an experienced investigator with experience working in the biopharma industry.
The Investigator I is responsible for maximizing organizational learning and improvement from Quality and Safety deviations. The incumbent partners with stakeholders from all areas of the business to ensure actions taken as a result of findings prevent or mitigate the risk of future recurrence. The incumbent ensures effective communications to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines. The incumbent ensures investigations are conducted in alignment with Quality Management System requirements and governing safety regulations, and presents investigative findings during audits as requested.
Leads investigations for Quality and Safety deviations and incidents. Conducts Quality and Safety investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations. May support complex and/or high impact investigations. Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
Documents investigation reports and findings in designated Quality and Safety systems. Ensures required management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders.
Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
Presents investigations during internal and external audits.
Working hours: 8:00 AM - 5:00 PM
--Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
--Effective facilitation skills.
--Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
--Ability to interpret technical information and documentation used for operations and production activities.
--Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
--Experience in performance improvement with basis in Human and Organizational Performance principles.
--Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
--Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy.
--Strong oral and written communication skills.
--Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.
B.S. degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline
A minimum of 3-5 years of experience in a lab and operations environment (industrial/plant experience preferred)
Please apply at Randstadusa.com. Interviews will start in the next week or so.
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