Summary
Overview
Work History
Education
Skills
Timeline
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Nydia Price

Oakland,CA

Summary

Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills. In-depth Quality Assurance Specialist with success in prioritization and multitasking. Exceptional communication and organizational skills. Committed to paying impeccable attention to reviews and auditing procedures. Thorough Quality Assurance Specialist with a 20-year background in Biotechnology. Excellent resource management and allocation skills. Outstanding communication, organizational, and time management talents. Thorough Quality Assurance Specialist with 20 years of background in Biotechnology. Excellent resource management and allocation skills. Outstanding communication, organizational, and time management talents. Thorough Quality Assurance Specialist with a 20-year background in Compliance. Excellent resource management and allocation skills. Outstanding communication, organizational, and time management talents. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Applies excellent attention to detail and critical reasoning to successfully conduct experiments. Reliable Quality Control Specialist with abilities in blueprint interpretation, operations monitoring, and quality control inspections. Outstanding communication, active listening, and organizational talents. Physically fit and adaptable with the capability to work in various work environments.

Overview

19
19
years of professional experience

Work History

Sr. Quality Associate

Amyris
11.2020 - Current
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Analyzed quality and performance data to support operational decision-making.
  • Monitored product standards and quality-control programs.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Implemented process improvements to increase productivity in quality assurance operations.
  • Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
  • Addressed non-conformance issues, pausing production to correct errors.
  • Fixed identified issues to improve workflows.
  • Fixed identified issues to increase productivity and boost workflows.
  • Updated inspection journals and daily summary logs with quality-related data.
  • Performed standard first article inspections and random sampling inspections to verify adherence to customer standards.
  • Created and collaborated in implementation and maintenance of customer complaint log.
  • Liaised with vendors and end-users to uncover system optimization opportunities.
  • Reported problems and concerns to management.
  • Inspected items and compared them against standards to meet regulatory requirements.
  • Collected and analyzed data to measure the effectiveness of quality control processes.
  • Performed tests and inspections to conform to established standards.
  • Inspected raw materials and finished products to verify quality and disposed of items that did not meet safety requirements.
  • Reviewed production processes and identified potential quality issues.

Quality Systems

Profusa
10.2019 - 02.2020
  • Within our Quality System, this role is responsible for document control, records management, supplier management, CAPA coordinator, and complaint handling, and serves as the training coordinator
  • Additional duties include maintaining compliant supplier records, archiving and storage of quality records, and conducting internal audits
  • This position is responsible for ensuring that all records created and maintained by the company follow FDA, ISO, QSR, quality, safety, and environmental regulations
  • Oversee and lead the Quality System metrics program to create timely status reports for executive management and ensure key Quality Sub-Systems are being properly maintained
  • Manage the Quality System records storage and archival processes, assist in the record-keeping development and tracking of critical quality processes such as CAPA, Complaints, Internal/External audit findings, and Non-Conforming Reports
  • Serve as the company Training Coordinator to initiate, monitor, and record training assignments and completions for all personnel
  • Maintain metrics and routinely report training status to executive management
  • Manage the External Standards program to ensure the latest standards are obtained, used, and referenced in reports and protocols
  • Create and maintain supplier files with required documentation and manage and maintain the Approved Supplier List ensuring follow-up requirements (evaluations and audits) are met
  • Conduct duties as a Quality System Internal Audit and Receiving Inspector ensuring compliance to regulations and internal procedures
  • Support the document control function as needed ensuring documents are initiated, reviewed, revised, filed and archived in a timely and compliant manner
  • Perform other Quality System duties in support of the Quality Assurance function as needed.
  • Determined quality department standards, practices, and procedures.
  • Established and tracked quality department goals and objectives.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.
  • Scheduled and chaired quality review meetings to review the effectiveness of performance mitigating risk, improving throughput, and achieving customer satisfaction.
  • Scheduled and chaired quality review meetings to review the effectiveness of performance mitigating risk, improving throughput, and achieving customer satisfaction.
  • Applied coaching techniques and tools to support managers and team members in improving performance.
  • Scheduled and chaired quality review meetings to review the effectiveness of performance mitigating risk, improving throughput, and achieving customer satisfaction.
  • Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput, and achieving customer satisfaction.
  • Inspected products and worker progress throughout production.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Reported production malfunctions to managers and production supervisors.
  • Specified quality requirements of raw materials with suppliers.
  • Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
  • Assured consistent quality of production by implementing and enforcing automated practice systems.
  • Evaluated interactions between associates and customers to assess personnel performance.
  • Skilled at working independently and collaboratively in a team environment.
  • Implemented new quality assurance and customer service standards.
  • Recorded, analyzed, and distributed statistical information.
  • Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
  • Prepared, documented and executed detailed test plans, test cases and defect reports
  • Reviewed and approved quality requirements for purchase orders and engineering specifications to meet contract compliance
  • Supported root cause and data analysis for defect reduction and process yield improvement
  • Created product specification notebooks, reducing defects on parts by 100%
  • Performed and coordinated 50 inspections and determined quality assurance testing models of raw materials and finished products
  • Interfaced with suppliers, inspectors, and clients to resolve outstanding non-conformance issues prior to shipment
  • Performed and coordinated 100% inspections and determined quality assurance testing models of raw materials and finished products
  • Created product specification notebooks, reducing defects on parts by 100%
  • Interfaced with suppliers, inspectors and clients to resolve outstanding non-conformance issues prior to shipment
  • Designed and developed forms and instructions to evaluate, assess and report quality standards and data
  • Devised and implemented best quality practices and processes for product development
  • Monitored and optimized production processes to increase throughput and improve quality
  • Led root cause analyses to identify and address problems in industrial production
  • Developed and implemented process improvements to reduce costs and increase efficiency in industrial production
  • Reduced downtime and increased production capacity with strong maintenance plans
  • Wrote safety procedures for industrial facilities, enforcing or exceeding industry standards
  • Created and implemented project plans for new or improved industrial processes
  • Developed and deployed industrial automation systems, increasing efficiency and reduce costs
  • Built inventory management systems for industrial facilities and reviewed existing systems to identify potential for optimization
  • Evaluated proposed project investments by conducting cost-benefit analyses

Quality Systems Coordinator

Genentech SSF
04.2018 - 10.2019
  • This is responsible for scanning GMP documents using FileNet
  • Other duties include shelving documents and labeling QA file room contents, performing document audits, and generating reports at requested intervals
  • Effectively follow SOPs, policies, and cGMPs
  • Adhere to and enforce policies and procedures related to Quality
  • Led follow-up on compliance deviations uncovered during audits
  • Communicating results of the internal audit program to site and Quality Management
  • Led follow-up of CAPAs related to internal audits to monitor for timely completion.
  • Archived quality audit reports and generated searchable index to facilitate improved report access.
  • Collaborated with internal subject matter experts to perform data reconciliations and produce credible results.
  • Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines.
  • Participated in targeted customer audit initiatives and produced required documentation to support verifiable results.
  • Maintained quality system documentation and updated specific documents to reflect new audit or test results.
  • Tracked corrective action reports and confirmed the closure of corrective action requests to demonstrate adherence to quality standards.
  • Performed data entry tasks and verified that charts and graphs produced accurate representations of data inputs.
  • Monitored active and inactive department rosters and updated the database to reflect employee additions and deletions.
  • Scheduled and managed internal and supplier-based audits to verify compliance with document control procedures.
  • Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.
  • Determined quality department standards, practices, and procedures.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Established and tracked quality department goals and objectives.
  • Monitored active and inactive department rosters and updated the database to reflect employee additions and deletions.
  • Monitored active and inactive department rosters and updated database to reflect employee additions and deletions.
  • Worked with users to maintain accurate quality records and supporting materials to document quality-related activities.

Quality Associate II

Baxter Bioscience
02.2005 - 04.2017
  • Perform cGMP/cGLP audits of internal departments and external contractors
  • Manage, evaluate, and approve Quality System documentation including deviations, CAPA’s, and planned changes
  • Evaluate document changes for compliance requirements
  • Evaluate compliance of completed manufacturing documents (batch records forms, etc.) and completed QC/QA documents (test results, analytical methods, and bills of testing, etc.) according to Production schedules
  • Participate as required in investigatory teams to resolve major quality issues
  • Participate in compliance audits of quality systems
  • Reviews device history records, manufacturing records, and Quality Assurance records to verify that the information is accurate and complete and that all the specifications have been met
  • Closely follows all procedures and specifications and is accurate in performing tasks
  • Experience in or familiarity with regulatory requirements such as FDA GMP, ISO 13485, and Quality Systems Regulations
  • Familiar with current software such as Microsoft Excel, Word, Access, which are used in generating reports and statistics
  • Experience in conducting training sessions with staff
  • Archive and box Quality Records off-site
  • Perform activities related to nonconformance, corrective actions, and effectiveness checks in one Microbiology department
  • Performs complex testing (Bacteriostasis/ Fungi stasis, etc.) on finished products and in-process samples
  • Routine Endotoxin Testing KQCL) Testing and Gel clot
  • Routine Environmental Monitoring of Device and Biologics Cleanrooms
  • Microbial Identification using the BIOLOG/Microlog-3, and the Vitek-2 Compact
  • Performs investigational work in support of out-of-specification samples, using training and scientific method to identify root causes and corrective actions
  • Documents and processes samples in a Laboratory environment
  • Serves as a trainer for other individuals in the Laboratory
  • Leads continuous improvement activities
  • Cross-trains and supports multiple departments in the Microbiology group
  • Investigates and authors Microbiology investigations
  • Enter test data into Laboratory Information Management System (LIMS)
  • Serves as a subject matter expert for Microbiology in client and regulatory audits
  • Performs complex routine and non-routine sampling and processes samples in support of the Microbiology department
  • Performs complex testing
  • Participate in continuous improvement initiatives such as QLP, LEAN, and 6-Sigma
  • Experience writing and approving Training, Deviations, Exceptions, CAPA’s, and/or other Non-conformances using (QMS) Trackwise Software
  • Establish and maintain, in conjunction with manufacturing and quality assurance, safety strategies to ensure that the appropriate cGMP guidelines are met, implemented, and maintained
  • Write Microbiological Qualification Protocols for R&D and Other Baxter Facilities
  • Implement standard methods and procedures for inspecting, testing, and evaluating all phases of product manufacturing in accordance with cGMPs and other regulatory requirements
  • Performs and reviews test data which includes overall documentation practices
  • Perform advanced microbiological assays requiring precise analytical skills and an understanding of microbiological principles.
  • Addressed non-conformance issues, pausing production to correct errors.
  • Promoted adherence to quality standards by educating personnel on quality control.
  • Fixed identified issues to increase productivity and boost workflows.
  • Updated inspection journals and daily summary logs with quality-related data.
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
  • Analyzed quality and performance data to support operational decision-making.
  • Monitored product standards and quality-control programs.
  • Educated employees on specific QA standards and confirmed maintenance of standards.

Education

High School Diploma -

Berkeley High School
Berkeley, CA
1997

Some College (No Degree) - Health Administration

San Francisco State University
San Francisco, CA

Bachelor of Science - Communications

University Maryland Global Campus
Adelphi, MD
09.2023

Skills

  • KNOWLEDGE & EXPERIENCE:
  • Proficiency in word processing, spreadsheet and presentation software
  • Good grasp of industry processes and existing business regulations
  • Excellent analytical skills
  • Ability to solve problems when they arise
  • Excellent interpersonal skills
  • Personnel Management
  • Deviation Correction
  • Document Quality
  • Retention Strategies
  • Communication Proficiency
  • Team Leadership
  • Verbal and Written Communication
  • Collaboration Skills
  • Quality assurance procedures
  • Clinical Quality Improvement
  • Quality Management System Compliance
  • Quality storage
  • Internal Quality Audits
  • Quality Improvement Program
  • Quality Assurance Committee Member

Timeline

Sr. Quality Associate

Amyris
11.2020 - Current

Quality Systems

Profusa
10.2019 - 02.2020

Quality Systems Coordinator

Genentech SSF
04.2018 - 10.2019

Quality Associate II

Baxter Bioscience
02.2005 - 04.2017

High School Diploma -

Berkeley High School

Some College (No Degree) - Health Administration

San Francisco State University

Bachelor of Science - Communications

University Maryland Global Campus

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Nydia Price