Lead Lab Quality Assurance Analyst
The position is direct to hire. This individual will focus on Analytical Data Review and must be familiar with applicable cGMP regulations and system and can make decisions based on those requirements. They will be responsible for evaluating the compliance of analytical documents such as test methods, stability and release data, protocols, SOPs, etc. with minimal supervision. This individual will function as a primary role within the Quality Assurance Department and must demonstrate excellent communication, critical thinking, and organizational skills.
- Audit data packages for scientific merit, GDP, and compliance to internal procedures
- Data review including but not limited to analytical testing data supporting product release, incoming material testing, stability studies and qualification, validation and/or verification related studies and laboratory equipment logbooks
- Review Certificate of Analysis, Certificate of Testing, test methods, product specifications for accuracy and compliance
- Review and approve documents using the change control process
- Review and approve stability protocols, data tables, laboratory quality protocols, and other laboratory quality records
- Assist Quality Systems group with regards to quality training of the laboratories
- Develop and implement appropriate Corrective and Preventive Action (CAPA) plan actions as means of continuous improvement
- Responsible for the timely closure of assigned quality records
- Participate in inspection readiness activities and assists in inspections by regulatory authorities (FDA/DEA)
- Serve as subject matter expert for quality oversight of the laboratory in regulatory audits.
- Evaluate laboratory quality metrics and leads CAPA or continuous improvement initiatives based on data
- Identify improvements/new procedures/compliance gaps based on applicable regulations for GMP operations
- Review logbooks for accuracy, completeness, compliance to company standard operating procedures and regulatory guidelines/regulations
- Maintain and issue logbooks to the laboratory as needed
- Maintain, issue, and reconcile serialized forms
- Perform internal audits according to schedule to identify areas of concern and/or process improvements based on current Federal Regulations
- Perform vendor audits of third-party laboratories
- Utilize knowledge of good documentation practices and good laboratory practices daily
- Provide quality support to laboratory material receipt, controlled substance program, pest control, calibration, stability, and other laboratory needs
- Execute and/or approve annual product review (APR) reports
- Minimum 4-year degree in a Science or Engineering field of study
- 3-5 years' of applicable cGMP industry experience, Analytical laboratory, QC laboratory, Manufacturing,
- Relevant laboratory experience within pharmaceutical or biopharmaceutical industry
- Familiarity with HPLC/GC data interpretation.
- Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
- Experience working with cross-functional groups such as planning, manufacturing, packaging, and distribution to ensure proper priorities are set and necessary activities are planned to meet these goals
cGMP ConsultingPleasant Prairie, WI
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