Brenda Cotter
Senior Quality Assurance Manager
Brunswick,OH
Summary
Organized and dependable Quality Assurance Manager successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
20
20
years of professional experience
1
1
Certificate
Work History
Senior Quality Assurance Manager
Athersys
Cleveland, OH
01.2019 - Current
- Promotion: Review/approve complex technical batch records and deviations from CMO for accuracy and quality issues
- Lot Disposition and Release
- Review Regulatory documents (IND amendments, IMPD) prior to submission to FDA, PMDA, EMA
- Review Clinical Operations documents (investigator Brochure, DSUR)
- Manage Change Controls
- Facilitated a 30% reduction in Change Control Cycle time
- Review/Approval of Complaints, CAPAs Deviations
- Auditing (internal and external)
- Train new associates
- Revise Batch records and SOPs
- Compile data and create quality metrics
- Established and tracked quality department goals and objectives.
- Update, review and approve master batch records, protocols, stability studies, raw material specifications and other CMO related documents
- Assist with Clinical Trial desktop audits, SOPs etc
- Collaboration with CMOs in Japan, Germany, The Netherlands and the US
- QMS administrator
Quality Assurance Manager
Athersys
Cleveland, OH
07.2017 - 01.2019
- Review complex technical batch records from CMO for accuracy and quality issues
- Lot Release
- Review Regulatory documents prior to submission to FDA, PMDA, EMA
- Managed Change Controls
- Auditing
- Trained new associates
- Revise Batch records and SOPs
- Assist with Clinical Trial desktop audits, SOPs etc.
Quality Supervisor
Synapse Biomedical
Oberlin, OH
10.2012 - 07.2017
- Oversaw department of 4 by supervising daily operations, providing technical support and coordinating personnel.
- CAPA review board member.
- Directed and supervised 4 employees involved in product inspection and quality control procedures.
- Supported audits and led teams to fully investigate quality control processes and root out deficiencies.
- Continuation of duties of Quality Associate III
Quality Control Engineer
Affymetrix/USB
Warrensville Heights, OH
05.2009 - 10.2012
- Creation and updating Biochemical product specifications
- Creation of Certificate of analysis for product sales
- Reviewing batch records for completeness and correctness
- Interfacing with multiple departments to answer quality questions and solve problems
- Data analysis
- Releasing qualified products through JD Edwards for company use
- Member of Materials Review Board
- Member of lean manufacturing initiative for Quality Control department
- Audit team member
- Team member for ISO conversion from 9001:2001 to 13485.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Escalated concerns about project and process quality, referring discovered issues to Quality Manager for correction.
Quality Associate III
Synapse Biomedical
Oberlin, OH
08.2007 - 01.2009
- Maintain company quality management system in compliance with medical device regulations and standards
- Gather and report quality information
- Assure company products are manufactured to meet requirements and specifications
- Perform internal audits
- Create and manage Engineer Change Notices, non-conformances, reworks and deviations
- Incoming and finished goods inspection
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions
- Document control.
Production Technician
Bayer Diagnostics
Oberlin, OH
01.1996 - 01.2001
- Operated, calibrated, and performed assay and system troubleshooting on ACS:180, ACS:180SE and Advia Centaur immunodiagnostic analyzers
- Trained new technicians on instrumentation, processes and Lotus Notes
- Aided in validation of new instrument software
- Assisted in annual CE mark testing
- Worked on team that maintained failure reporting database which was used to track and determine corrective actions for process and supplier issues
- Reengineered processes to improve clarity and conciseness
- Performed special testing of acid lines to help identify and correct defective manufacturing process and of instrumentation to identify software bugs.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Tested selected products at specified stages in production process for performance characteristics or adherence to specifications
Education
Bachelor of Science - Biology
Cleveland State University
Cleveland, OH06.1996
Skills
- ASQ CQA
- GLP/cGMP
- Raw Material Inspection
- Final Product Approvals
- Internal/External Audits
- Quality Systems
- Process Documentation
- Attention to Detail
- Quality Assurance Inspections
- Current Good Manufacturing Practices (CGMP)
- JDEdwards, Fourth shift, Microsoft Access, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Lotus Notes, ensur, Visio, D365
Certification
- CQA - Certified Quality Auditor
Timeline
Senior Quality Assurance Manager
Athersys
01.2019 - Current
Quality Assurance Manager
Athersys
07.2017 - 01.2019
Quality Supervisor
Synapse Biomedical
10.2012 - 07.2017
Quality Control Engineer
Affymetrix/USB
05.2009 - 10.2012
Quality Associate III
Synapse Biomedical
08.2007 - 01.2009
Production Technician
Bayer Diagnostics
01.1996 - 01.2001
Bachelor of Science - Biology
Cleveland State University
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