Germer International - Pharmaceutical Recruiting ยท 1 week ago
Lead Specialist, QA Investigations
Burlington, VT
Full-time
Onsite
Senior Level
$90K/yr - $130K/yr
4+ years expGermer International is a Fortune 500 Pharmaceutical Company with Global reach, currently seeking a strong Senior Specialist to join their tenured QC team. The role involves leading complex investigations, mentoring QA Specialist Investigators, and ensuring compliance with quality standards.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Les Schafer 484-684-6154
Responsibilities
Lead critical / complex investigations of incidents, issues, and trends. Leads / facilitates cross functional structured problem solving in support of investigations. Propose associated CAPA actions and prepare associated investigation reports
Lead / participate in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact
Provides mentorship and supports training/development of QA Specialist Investigators
Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides. Present to local and vertical leadership as required. Prepare and/or approve associated reports
Performs review/close out and effectiveness checks of completed CAPA, in accordance with the approved CAPA
Leads periodic and special cause trending assessments to determine corrective actions to address trends. Prepare periodic reports as assigned
Leads continuous improvement project teams, as well as owns and executes department CAPA as assigned. Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion
Authors new or revised site procedures as assigned. Prepares and provides training related to investigations, site procedures and cGMP as assigned
Approves laboratory investigations, incidents, and investigations as authorized
Qualification
Required
Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration
Must possess a working knowledge of cGMP, Quality Systems, and root cause analysis techniques
Must understand the cGMP standards for the investigation of non-conformances and the contents of investigation reports
Ability to add, subtract, multiply and divide
Statistical Analysis, Advanced Mathematical calculations
Must possess strong communication skills (written and verbal)
Must have experience in technical writing
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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