Germer International - Pharmaceutical Recruiting · 2 weeks ago
Lead Specialist, Quality Assurance
Burlington, VT
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expGermer International is a leading global pharmaceutical company seeking a senior QA professional to join their expanding team. The role involves leading training, providing oversight of QA operations, and participating in quality improvement activities.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Jessica Gerber
Responsibilities
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
Qualification
Required
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
Company
Germer International - Pharmaceutical Recruiting
Welcome to Germer International! We're a Life Sciences search & placement firm that focuses on building long-term partnerships with small and mid-sized companies across the country.
11-50 employees
Funding
Current Stage
Early StageRecent News
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