Quality Assurance Management System
Resume:
Jaleel Faulk
Quality Assurance Specialist
An accomplished QA professional with strong years in progressive experience with an emphasis to ensure a quality management system enforces the required standards of safety, legality, quality, compliance and accreditation. Adaptable to understanding and using a variety of database systems. Skilled in maintaining aspects of controlling documents per 21CFR. ad2vye@r.postjobfree.com
East Boston, United States
SKILLS
LMS Veeva Vault
Administrative
Logging SAP
Multi-Task LabWare
Iron Mountain
SharePoint Training
OnBase EPIC
Microsoft Office
Quality Systems
Document Control
Audit Support
Project Managemet
Archive Management
Business Knowledge
INTERESTS
Graphic Design
Web Design
Video Editing
WORK EXPERIENCE
Package Handler
FedEx Express
09/2023 - Present, East Boston, MA
• Loaded products weighing up to 80-100 pounds onto trailers for delivery • Processed 100-150 packages per minute • Maintained a high level of attention to detail in order to ensure accuracy of all tasks performed.• Processed and packaged incoming packages for shipment, using hand-held scanners to verify package information • Assisted with loading trucks as needed and ensured proper safety procedures were followed at all times • Cleaned and maintained the warehouse in compliance with OSHA safety standards • Followed all company policies & procedures related to job duties and worked within the guidelines of the Quality Management System (QMS) Peer Specialist (Internship)
NAMI Boston
09/2020 - Present, Somerville, MA
• Terrific interpersonal and communication skills • Compassionate and empathetic regarding mental health issues and recovery • Excellent listening and oral communication skills • Good understanding of self-esteem building and managing negative self-talk • Strong understanding of ethics and client confidentiality • Provided assessment and referrals to other services as needed • Extensive experience with creating Wellness Recovery Action Plans with client peers • Able to tell own story and use it to help people know they are not alone • Facilitated support groups and assisted in creating a safe and comfortable environment for clients to express themselves. Operations Associate II
Biogen
05/2022 - 09/2022, Cambridge, MA, USA
• Maintain the highest standards of quality and cGMP compliance and ensure training is up to date on all duties being performed LabWare & Veeva Vault • Reviewed, approved, and monitored the implementation and effectiveness of corrective action plan Performed Quality System Reviews of batch records to help ensure that operational departments are prepared for external inspections and audits • Reviewed, approved, and monitored the implementation and effectiveness of corrective action plans • Experience in executing computer system validation deliverables such as User Requirements Specifications and qualification scripts • Scheduled time send & receive confidential documents from Iron Mountain
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WORK EXPERIENCE
Quality Systems Consultant
Sage Therapeutics
08/2021 - 02/2022, Cambridge, MA, USA
• Analyses, developed, tested, and deployed configuration, batch record workflow, and/or reported to improve the overall accuracy, efficiency, and effectiveness of the cGMP computerized system in TrackWise & Veeva Vault • Oversee upload of records into the electronic Document Management System (eDMS), in compliance with regulatory requirements • Help with the implementation of CAPA as determined through discrepancies • Created training modules for manager and upcoming employees • Supported during internal and external audits related to Regulatory and Internal audits for Documentation • Administration of LMS, DocuSIgn system; filing & archiving of training documents • Scheduled time to send & receive confidential documents from Iron Mountain Health Information Management
Partners Healthcare
01/2019 - 04/2020, Somerville, MA
• Accurately and efficiently processes, prepares, sorts, scans, indexes and performs quality review of batch record documents to be scanned into clinical systems within specified time • Prepares batches of documents including attaching document type and patient labels for scanning into the electronic document management system • Handled equipment and systems cGMP compliance, validation and project management • Help with the implementation of CAPA as determined through discrepancies
• Adhered to retention requirements on documents • Provided staff with ongoing feedback, direction and guidance to ensure a well-motivated and productive workgroup DIESEL
Sales Associate
01/2019 - 11/2019, Boston, MA
Fulfilled all retail clerk duties in a high-end sales outlet. Handled customer-service including POS, sales, and inventory management.• Convinced customers to sign up for reward program loyalty leading to an average of 50+ repeat customers per month.• Maintained high-level product knowledge. Received 95% positive marks for conveying product features and benefits, as reported in customer surveys • Kneeling, stooping, using stairs, reaching, pulling and moving weights of 5- 50lbs constantly and moving weights of 5-50lbs constantly and team lift for anything over 50lbs Retail Specialist
Clarks
06/2015 - 08/2018, Boston, MA
• Maintained monthly sales for 300+ customers and completed 170+ daily transactions in the first month. • Accomplished sales goals within 11 weeks on the job by establishing a positive rapport with 50+ customers and identifying their needs. • Provided prompt information regarding services, promotions, and location of 720+ products within the store. • Utilized creative marketing displays using 20+ flyers, 300+ coupons, and 130+ advertisements to increase customer awareness and store traffic by 80%
EDUCATION
Associates in Science - Business Administration and Management Roxbury Community College
09/2010 - 05/2014, Roxbury, MA, USA
Bachelors of Science - Business Administration and Management University of Massachusetts Boston
09/2023 - Present, Boston, MA, USA
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