Kelly Scientific Resources currently has a full-time permanent placement opportunity to join a growing drug-delivery device company developing innovative products to bring to market. We are seeking to fill a QA position overseeing QA review for manufacturing and QC/Analytical Development laboratories. The successful candidate will have excellent communication strengths to oversee projects and provide guidance within this area across the organization. Candidates with a strong analytical method development background that have transitioned into QA / Investigations are strongly encouraged to apply! This position is located in Research Triangle Park, NC.

Requirements:

• BS / MS in Chemistry, Chemical Engineering, or related discipline
• 7 + years in a quality role in the pharmaceutical industry
• Experience in a production environment, cGMP laboratory, or technical support role
• Use of USP and/or EP methodology and validation/transfer of analytical methods required
• Knowledge of UV-VIS; HPLC; FTIR; and LCMS required
• Working experience with Compendial Methods and Specifications
• Experienced in QA analytical techniques such as HPLC, GC, UV Vis, FTIR, Dissolution Test and other wet chemistry analysis using Compendial methods
• Experience with statistics, stability program development/maintenance and ability to analyze data and interpret results

Responsibilities:

• Provides QA review and approval of new and existing procedures, investigation documentation, and process control documents
• Provide first response for Quality and Compliance issues on the manufacturing floor and the laboratories.
• Leads teams using trend and investigational data to create value through process improvements and failure reduction activities
• Provides review and approval of deviations, investigations, protocols (validation, equipment, process, and production)
• Review of process, cleaning, method validation protocols, analytical test method transfers, reports and discrepancies
• Independently identify failure modes and related process improvements by facilitating teams to determine cause
• Uses data trends to work with operating departments to facilitate process improvement
• Leads and/or participates in scheduled and unscheduled audits of operational areas
• Provides backup to Record Review for final review/release of production batch records
• Provides QA approval for Change Control; Deviations; Lab Inquiries/OOS Investigations; Process, cleaning method validation protocols, reports and discrepancies; Equipment/facilities qualifications, protocols / reports; Specifications, methods and Facility controls/instruments and procedures
• Provides QA representation on raw material issues team ensuring information continuity for incoming quality concerns through Supply Chain to vendors

For immediate consideration, please click Apply Now!

Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer.