Asizah Grimes
Memphis,TN
Summary
Experienced and detail-oriented professional with extensive experience in the pharmaceutical and medical device industries. Proven track record performance management and supervising manufacturing operations. Skilled in implementing quality management systems, conducting risk assessments, and leading cross functional teams to achieve quality objectives. Proficient in FDA regulations, GMP guidelines, and ISO standards. Excellent analytical and problem-solving abilities to identify root causes and implement effective corrective actions. Decisive Production Supervisor exceptionally skilled at identifying measures to improve production methods and equipment performance. Consistently achieved inventory goals and maintained minimal downtime for production lines.
Overview
11
11
years of professional experience
Work History
Quality Engineer
Flextronics
05.2023 - Current
- Lead root cause analysis to determine core reason for failures and errors.
- Maintained amiable relationships with suppliers through difficult quality control issues, supporting healthy business interactions.
- Identified gaps in existing compliance processes and recommended updates.
- Perform Internal and External Audits to ensure adherence to standards.
- Manage CAPAs, CAR, and investigations for site non-conforming issues.
- Collaborated with cross-functional teams to conceptualize and NPI product concepts.
Quality Engineer Consultant
Stryker
01.2022 - 05.2023
- Experienced and detail-oriented Quality Engineer with extensive experience in the pharmaceutical and medical device industries
- Proven track record in ensuring compliance with regulatory requirements, driving continuous improvement, and maintaining product quality
- Skilled in implementing quality management systems, conducting risk assessments, and leading cross functional teams to achieve quality objectives
- Proficient in FDA regulations, GMP guidelines, and ISO standards
- Excellent analytical and problem-solving abilities to identify root causes and implement effective corrective actions
- Strong communication and collaboration skills to work effectively with internal teams and external stakeholders
- Dedicated to delivering high-quality results and contributing to the overall success of the organization.
Operations Supervisor
GSK Consumer Healthcare
12.2018 - 12.2021
- Supervise and coordinate the activities of operational staff, providing guidance, support, and performance feedback to ensure efficient and effective operations
- Ensure compliance with operational policies, procedures, and standards, including safety guidelines and quality requirements
- Train, onboard, and mentor new employees, ensuring they understand their roles, responsibilities, and operational procedures.
- Set, enforced, and optimized internal policies to maintain responsiveness to demands.
QA Compliance Team Lead
GSK Consumer Healthcare
09.2015 - 12.2018
- Conduct regular audits and assessments to evaluate the effectiveness of internal controls and identify compliance gaps or areas for improvement
- Provide guidance and training to employees on compliance policies, procedures, and best practices to foster a culture of compliance awareness.
- Developed and maintained compliance database, tracking all compliance activities and documents.
- Monitored and assessed compliance risks associated with operational processes and procedures.
Manufacturing Engineer Intern
Smith & Nephew Inc.
01.2014 - 12.2014
- Assist in investigating and troubleshooting quality issues, analyzing root causes, and implementing corrective and preventive actions
- Participate in the development and improvement of manufacturing processes, including documentation of procedures, work instructions, and process flowcharts
- Assist in conducting internal audits to assess compliance with quality management systems, regulatory requirements, and industry standards.
- Confirmed that manufactured work products met customer requirements as designated by company policies and design control procedures.
Quality Assurance Specialist
Teleflex
02.2013 - 09.2015
- Conduct visual inspections, measurements, and functional testing to verify product conformity and identify any deviations or defects
- Collect and analyze quality data, including inspection records, test results, and nonconformance reports, and maintain accurate and organized documentation
- Assist in the development and implementation of quality control procedures, work instructions, and standard operating procedures (SOPs).
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Education
Bachelor of Science - Biology
University of Memphis
Memphis, TN12.2024
High School Diploma -
Hollis F. Price Middle College High School
Memphis, TN05.2008
Skills
- Regulatory Compliance
- Microsoft Office Suite
- Validation and Qualification
- Quality Management Systems
- Quality Standards and Regulations
- Leadership
- Technical Writing
- Multi-task management
- Auditing
- Problem Solving
- Failure Investigation and Analysis
- Non-Conformance Reports
- FMEA
- PPAP Submissions
- GD&T
- Six Sigma Methodologies
- Decision Making
- Scheduling and Planning
- Performance Measurement
- Team Leadership
- Employee Development
- KPI Tracking
Accomplishments
- Promoted from Technician I to Technician II (Teleflex Medical)
- Improved Quality Inspections Time and Accuracy (Teleflex Medical)
- Apart of the implementation of 3E digital codes (Smith & Nephew)
- Promoted to Leadership Role (GSK)
- Help Modify SOP(s) and Work Instructions based on Regulatory Audit Finding (GSK)
- Internal Auditor Certified -ASQ (Teleflex)
- Employee of the Month (GSK)
- Heavily involved in process improvements/ Project Managing (GSK)
- Reduce Documentation Errors BNRFT by 48% (GSK)
- Reduce Deviations by 33% (GSK)
- Promoted from Compliance Specialist to Operation Supervisor (GSK-2017)
- Promoted from Operations Supervisor to Operations Manager (GSK-2018)
- Worked on Integration Remediation Team (Stryker 2022)
Timeline
Quality Engineer
Flextronics
05.2023 - Current
Quality Engineer Consultant
Stryker
01.2022 - 05.2023
Operations Supervisor
GSK Consumer Healthcare
12.2018 - 12.2021
QA Compliance Team Lead
GSK Consumer Healthcare
09.2015 - 12.2018
Manufacturing Engineer Intern
Smith & Nephew Inc.
01.2014 - 12.2014
Quality Assurance Specialist
Teleflex
02.2013 - 09.2015
Bachelor of Science - Biology
University of Memphis
High School Diploma -
Hollis F. Price Middle College High School