BRYAN WADE
CAPS
Bethlehem,PA
16
years of professional experience
Detail-oriented Quality Assurance professional with over 10 years in pharmaceutical manufacturing, packaging, and compliance. Expertise includes batch record review, in-process inspections, CAPA management, and GMP compliance. Contributions include process improvements, backlog reduction, and effective training, ensuring product quality and regulatory adherence. Reliable team player with adaptability and critical thinking skills, adept in problem-solving and quality management.
Work History
Quality Control Coordinator
5 Years 7 Months- Advised in restructuring company internal processes during three remediation operations including developing Supplemental Batch Records and Electronic Batch Records for compliance and optimization.
- Trained 10 new and current employees as a Subject Matter Expert in Batch Record release, enhancing team competency and process accuracy.
- Streamlined raw material discrepancy resolution, enhancing release processes and driving continuous improvement initiatives as SAP superuser.
- Conducted regular inspections on finished goods and raw materials, identifying and addressing discrepancies to ensure production quality.
- Utilized Vaisala and Beckmans EM Monitoring, LANCE, TrackWise, SAP, and MasterControl for batch record releasing and nonconformance events.
- Facilitated cross-departmental communication to resolve quality concerns swiftly and enhance collaborative responses to issues.
- Conducted investigations for Nonconformance events, Supplier Corrective Action Reports, and Customer Complaints to uphold product quality and regulatory standards.
Quality Assurance Inspector
1 Year 8 Months- Conduct and oversee in-process quality inspections for pharmaceutical manufacturing and packaging operations including visual, analytical, seal, torque, and Instron testing.
- Reviewed and released batches for disposition, ensuring adherence to regulatory standards and maintaining product integrity.
- Created and investigated quality deviations, complaints, and nonconformance events while ensuring compliance with GMP requirements.
- Created and investigated quality deviations, complaints, and nonconformance events, ensuring compliance with GMP requirements and facilitating corrective actions.
- Trained and mentored QC personnel on testing methods and documentation practices, fostering a culture of quality assurance and consistent compliance.
- Obtained Vaprox Hydrogen Peroxide Sterilant certification for Phase III operations.
Quality Systems Associate
1 Year 6 Months- Managed customer and consumer complaint investigations, ensuring timely resolution and compliance with quality standards with a 70% reduction in complaint backlog.
- Conducted functional testing on field and retain samples, verifying adherence to manufacturing and packaging specifications while reviewing batch records.
- Partnered with executive leadership to maintain complaint investigations, annual product reviews, laboratory investigations, and Quality Systems processes.
- Facilitated integration of TrackWise Quality Management System with complaint management processes to enhance data tracking and reporting.
- Revised SOPs, CAPAs, and quality deviations to improve compliance and operational consistency.
Quality Assurance Auditor
1 Year 2 Months- Reviewed and approved batch records, deviations, CAPAs, and SOPs to ensure compliance with quality standards.
- Validated, controlled, and archived Quality Management System documentation.
- Collaborated with Operations teams to identify and resolve quality issues, facilitating effective corrective actions.
- Guided in investigations of atypical events and compliance concerns to support regulatory adherence.
Coordinator / Supervisor
2 Years 6 Months- Led daily operations of a team of 4 operators as an Almac-contracted Production Coordinator in general manufacturing.
- Conducted in-process inspections and approved batch records to ensure compliance with quality standards.
- Streamlined integration of physical room and equipment logbooks into Syncade Quality Management System, enhancing documentation efficiency.
Production Coordinator II
2 Years 1 Month- Conducted in-process inspections and prepared batch documentation, ensuring compliance with regulatory standards.
- Collaborated with customers during production operations, enhancing communication and ensuring successful project execution.
- Facilitated peer training and coordinated personnel assignments to strengthen team capabilities and support project goals.
Team Lead Supervisor
1 Year 8 Months- Led assembly-line personnel in assembly and quality control processes, ensuring high standards for John Deere 8000 Series hydraulic lift systems.
- Troubleshot product failures and supervised testing operations to enhance product reliability.
Education
Bachelor of Arts - Media Studies, Communications
Skills
GMP Compliance
Quality systems
Batch Record Review
Quality Control Testing
Complaint Investigations
CAPA Management
Deviation Investigations
SOP oversight
TrackWise
Root Cause Analysis
Microsoft Office Suite
Timeline
Quality Control Coordinator
CAPS
01.2021 - CurrentRead More
Quality Assurance Inspector
SHARP SERVICES
04.2019 - 12.2020Read More
Quality Systems Associate
ACCUPAC, INC.
09.2017 - 03.2019Read More
Quality Assurance Auditor
ALMAC CLINICAL SERVICES
07.2016 - 09.2017Read More
Coordinator / Supervisor
GLAXOSMITHKLINE PHARMACEUTICALS
01.2014 - 07.2016Read More
Production Coordinator II
ALMAC CLINICAL SERVICES
12.2011 - 01.2014Read More
Team Lead Supervisor
BOSCH
03.2010 - 11.2011Read More
Pennsylvania State University
Bachelor of Arts from Media Studies, Communications
Read More