JOEL MGANI
Port Wentworth,GA
Summary
Quality Assurance professional with strong background in ensuring product integrity and compliance. Skilled in identifying system inefficiencies, implementing effective quality control measures, and enhancing operational processes. Known for fostering team collaboration and adapting to evolving project demands while consistently achieving high-quality results. Equipped with analytical skills, attention to detail, and commitment to continuous improvement.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
MERIT CRO
09.2022 - Current
- Utilized root cause analysis techniques to identify underlying issues contributing to product defects or customer complaints.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Collaborated with cross-functional teams to develop robust quality assurance strategies for new products.
- Streamlined the documentation process, ensuring adherence to industry standards and regulatory requirements.
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Enhanced customer satisfaction by addressing reported issues promptly and providing effective solutions.
- Achieved timely resolution of non-conformance issues by implementing corrective action plans working closely with relevant departments.
- Fostered culture of continuous improvement, organizing training sessions on latest quality assurance best practices.
- Conducted internal audits and assisted in the development of the internal audit schedule
- Assisted with scheduling and managing client and regulatory on-site visits and audits as assigned
- Conducted vendor and contractor qualifications and audits, including vendor and contractor maintenance activities
Quality Assurance Senior Associate
QOL Medical, LLC
07.2021 - 09.2022
- Performed quality review of master batch records for both drug substance and externally manufactured and packaged drug product, including but not limited to testing results and all supporting documentation
- Performed lot disposition activities for both drug substance and drug product
- Performed quality review and lot disposition for component specifications and associated labels
- Stability Program Owner, responsible for managing several stability studies and coordinating all associated time-point pulls
- Change Control Review Board (CCRB) coordinator, responsible for issuing change controls, reviewing documentation, and ensuring timely completion of action items
- Interfaced frequently with Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs) to coordinate batch record reviews, stability study initiation and time-point pulls, shipment of samples for release testing at contract laboratories, and final lot disposition
- Created, revised, and reviewed standard operating procedures and associated controlled documents
- Issued and distributed controlled documents throughout the organization
- Reviewed quality documentation for accuracy, completeness, and compliance with data integrity policies and cGMPs
- Performed maintenance of electronic filing systems
- Participated in conducting and hosting internal and external quality audits
- Assisted with the management of process and product-related quality records and continuous improvement efforts, including but not limited to initiation and support of deviations, CAPA's and lab investigations using ZenQMS software
Quality Control Inspector
Bausch Health
01.2020 - 07.2021
- Sampled and weighed various sterile and non-sterile raw materials to develop complete and commercially viable products
- Submitted finished product samples to laboratory for testing and approval
- Performed decontamination and environmental monitoring activities on aseptic and other classified work areas
- Utilized gauges and other equipment to complete in-depth assessments of various components
- Performed frequent visual inspections to root out tolerance and compliance issues
- Moved shipment materials to and from designated areas using lifts and pallet jacks
- Boosted inventory and recordkeeping accuracy by conducting thorough inspections and verifying shipment contents with documentation
QA/RA Specialist
SCC Soft Computer
07.2012 - 10.2019
- Coordinated and performed internal quality system audits
- Assisted with preparation and submission of Correction and Removal reports, MDRs and 510(k) to FDA and Health Canada
- Assisted with preparation and submission of Annual Establishment Registration and Device Listing on FDA website
- Served as a CAPA Team member participating in developing company's CAPA processes and CAPA automation system
- Performed document control activities such as developing, updating, reviewing, and approving Quality system documents to ensure compliance with FDA, ISO 13485 and MDSAP regulations
- Provided quality system data and analysis to management to assist with process improvements
- Assisted with training new hires on company quality system procedures and on becoming internal auditors
Education
Associate of Arts - Business Administration And Management
St. Petersburg College
Clearwater, FL12.2015
Skills
- Strong leadership and teamwork attributes
- Adaptable
- Organized
- Problem-solving
- Detail-oriented
- Analytical thinking
- Decision-making
- Customer service
- Documentation and reporting
- Risk management
Languages
Swahili
Native or Bilingual
English
Native or Bilingual
Certification
- Certified Quality Auditor (CQA) - American Society for Quality (ASQ). Completed December 2023
Timeline
Quality Assurance Specialist
MERIT CRO
09.2022 - Current
Quality Assurance Senior Associate
QOL Medical, LLC
07.2021 - 09.2022
Quality Control Inspector
Bausch Health
01.2020 - 07.2021
QA/RA Specialist
SCC Soft Computer
07.2012 - 10.2019
- Certified Quality Auditor (CQA) - American Society for Quality (ASQ). Completed December 2023
Associate of Arts - Business Administration And Management
St. Petersburg College
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