Job Description

Lead Specialist Quality Assurance

Are you looking to join a leading global pharamceutical company? Our client is looking for a senior QA professional to join their expanding team by leading training, as well as be on the manufacturing floor.

Key responsibilities for this role include:

• Directly participate in the Training and Development of QA Specialists/Senior Specialists/Supervisors in QA Operations functions and GMP regulations.
• Provide leadership and, as directed by management, daily oversight of the Quality Assurance Specialists
• Lead and participate in quality improvement team activities, and participate in cross-functional teams, providing QA input.
• Assist Management with strategic planning of intermediate batch record review/release, finished product batch record review, and other QA Specialist floor operations.
• Oversee QA Specialists’ evaluation and triage of events, deviations, and unplanned maintenance activities.
• Oversight of On-Hold material program, mentoring QA Specialists/Supervisors in monitoring and disposition of material.
• Perform QA review/approval of controlled documents, written procedures, protocols, and MES recipes, as required.
• Prepare and provide information for inclusion in monthly quality metric reports.
• Assure deviations are appropriately reported. Participate in investigations of deviations, as required.
• Support review and approval of Trackwise ® incidents related to manufacturing operations.
• Identify and implement continuous improvements for the elements of the quality system related to manufacturing operations.

The minimum qualifications for this role are:

• BS degree and 10+ years of relevant experience in a GMP environment, and comprehensive knowledge of Quality Systems and cGMP. A combination of experience and/or education will be taken into consideration.
• Must possess working knowledge of Quality systems for the Pharmaceutical Industry (cGMP, ICH and Pharmacopoeia requirements) and Medical Products (ISO, IPEC). Must possess knowledge and familiarity with computers and various software such as MS Word, MS Excel, MS Access and MS Project.
• Ability to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals, Ability to compute ratios and percent and to draw and interpret a variety of graphs and charts. Ability to apply basic statistical concepts to data.
• Effective written and oral communication and interpersonal skills, and an ability to constructively work across functional areas to achieve results.

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