Clinical Quality Assurance Career Research and Resources
Celera
Write validation master plans. Review, edit, and approve validation protocols and reports. Manage the corporate Risk Management program. Create new risk management SOPs and revise existing SOPs to ensuring regulatory compliance. Develop and provide training to risk managers and risk team members. Review and approve change controls and SOP document change requests.
Avg. Salary: $120,000 · Company Rank: Not Available
Genentech, Inc
As the Principal Validation Manager was responsible for oversight and scheduling of all validation and revalidation activities for the clinical and commercial aseptic processing and packaging manufacturing areas at both corporate and CMO sites. Managed and provided mentoring and training and supported career development to a staff of 8 direct report validation engineers including writing performance reviews. Hired and man...
Avg. Salary: $120,000 · Company Rank: Not Available
Genentech, Inc
Write and execute validation IQ/OQ/PQ protocols and write validation reports. Review and approve validation protocols and reports for validation contractors I was supervising. Review and approve change controls and SOP document change requests. Write and revise validation department SOPs. Participate in audits of CMO and supplier facilities. Present validation reports to auditors and inspectors during internal and exte...
Avg. Salary: $120,000 · Company Rank: Not Available
NJVC, LLC
Plan and execute corporate-level internal assessment program preparatory to building an ISO 9001:2008 compliant quality management system. Support teams responsible for program management including site conformance, issues management, and root cause analysis. • Implement corporate internal assessment program, including planning, execution, reporting, and action item tracking • Audit Media Generation Division against ISO ...
Avg. Salary: $75,000 · Company Rank: Not Available
SeraCare Life Sciences, Inc.
Primary responsibilities focused on maintaining quality improvement systems including internal auditing, CAPA, nonconformance reporting, and supplier management. Secondary responsibilities included product release and validation package review. Additionally, I supported customer-related programs including site visits, complaint resolution, and project Quality Plans.
Avg. Salary: $75,000 · Company Rank: Not Available
Capricorn Products LLC
Managed day-to-day administrative operations essential for a successful small immunodiagnostics manufacturing business. Key responsibilities included document change control, supplier management, purchasing, receiving, and shipping including international exports and dangerous goods.
Avg. Salary: $75,000 · Company Rank: Not Available
Human Genome Sciences, Inc
Supported maintenance of document control, records management, and archival programs; interfaced with internal customers to fulfill document requests and respond to archived document inquiries.
Avg. Salary: $75,000 · Company Rank: Not Available
Cadilla Healthcare Ltd.
• Worked in “In Process Quality Control” which included supervision of multiple step processes from manufacturing to packaging. • Worked with QA manager for the quality of product & Maintaining GMP System of the plant. • Reviewed stability studies of the product. • Prepared, reviewed and updated documents like Batch Records, SOP’s, and Protocols. • Assisted in performing CAPA in response to internal quality audit. • Perform...
Avg. Salary: $45,000 · Company Rank: Not Available
Stevens Pharmaceutical Research Club
• Analyzed, understand SOPs, and classifying them according to the department requirements. • Optimized various process parameters using statistical tools like design of experiment (DOE) and process capability to support the ongoing research project. • Implemented Risk map analysis by FMEA model application. • Applied Poke-Yoke tools to organize the lab activities. • Maintained GMP compliance working environment in the l...
Avg. Salary: $45,000 · Company Rank: Not Available
Pharmaceutics International, Inc.
• Created robust systems through, writing reviewing and approving standard operation procedures (SOPs) • Reduced compliance risks through investigation of processing discrepancies and product attribute trends, including customer complaints • Increased safety, performance and reduced cGMP issues by working directly with production personnel to address floor observations and documentation issues as they arose • Selected to up...
Avg. Salary: $60,000 · Company Rank: Not Available
