Jannel Reyes Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

- Effectively communicates and collaborates with internal QA, Manufacturing, Quality Control, Materials Management, Facilities, and Project Management- Leads the review and approval of executed production batch records to ensure records meet cGMP expectations- Performs the material release or rejection of final product- Participates in the quality oversight of events including out-of-specification results (OOS), deviations, corrective and preventive actions (CAPA), EM excursions… Show more - Effectively communicates and collaborates with internal QA, Manufacturing, Quality Control, Materials Management, Facilities, and Project Management- Leads the review and approval of executed production batch records to ensure records meet cGMP expectations- Performs the material release or rejection of final product- Participates in the quality oversight of events including out-of-specification results (OOS), deviations, corrective and preventive actions (CAPA), EM excursions, and change controls- Coaches cross-functional team members to ensure compliance with internal documents and applicable regulations- Provides training, leadership and guidance to QA personnel- Works with clients as their assigned QA representative to support any queries regarding batch record review and release activities and reports key metrics in business review meetings- Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and validation documentation- Coordinates and schedules quality functions to support Manufacturing operations- Manages batch release tracker and hosts weekly meetings with cross-functional teams- Monitors and communicates internal team metrics- Supports client, regulatory, and internal quality audits Show less

San Diego, California, United States

- Reviewed and approved production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices- Generated batch release paperwork such as Certificate of Compliance and BSE/TSE Statements- Worked with clients as their assigned QA representative to support any queries regarding batch record review and release activities and report key metrics in business review meetings- Developed, revised… Show more - Reviewed and approved production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices- Generated batch release paperwork such as Certificate of Compliance and BSE/TSE Statements- Worked with clients as their assigned QA representative to support any queries regarding batch record review and release activities and report key metrics in business review meetings- Developed, revised, reviewed and approved controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and validation documentation- Provide QA on-the-floor support and assesses daily manufacturing operations- Participates in the quality oversight of events including out-of-specification results (OOS), deviations, corrective and preventive actions (CAPA), EM excursions, and change controls- Performed internal audits and GMP area walkthroughs- Supported client and regulatory audits Show less

- Performed line clearance activities within an ISO 7 environment- Performed real-time review of documents on the manufacturing floor- Reviewed and approved production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices- Generated batch release paperwork such as Certificate of Compliance and BSE/TSE Statements- Represented QA on assigned clients, attends client meetings interacts… Show more - Performed line clearance activities within an ISO 7 environment- Performed real-time review of documents on the manufacturing floor- Reviewed and approved production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices- Generated batch release paperwork such as Certificate of Compliance and BSE/TSE Statements- Represented QA on assigned clients, attends client meetings interacts with clients and addresses client inquiries- Developed, revised, reviewed and approved controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and validation documentation- Identified, assessed, and investigated daily manufacturing operations- Participated in the quality oversight of quality reports including deviations, corrective and preventive actions (CAPA), EM excursions, and change controls Show less

San Diego, California

- Performed line clearance activities within an ISO 7 environment- Performed real-time review of documents on the manufacturing floor- Reviewed and approved production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices- Generated batch release paperwork such as Certificate of Compliance, and BSE/TSE Statements - Represented QA on assigned clients, attends client meetings interacts… Show more - Performed line clearance activities within an ISO 7 environment- Performed real-time review of documents on the manufacturing floor- Reviewed and approved production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices- Generated batch release paperwork such as Certificate of Compliance, and BSE/TSE Statements - Represented QA on assigned clients, attends client meetings interacts with clients and addresses client inquiries- Reviewed and approved controlled documents including Master Batch Records, analytical methods, protocols, and standard operating procedures (SOPs)- Identified, assessed, and investigated daily manufacturing operations- Reviewed deviations, EM excursions, and corrective and preventive actions (CAPA) Show less

San Diego, California

- Worked with clients and sent documents for review and approval- Sent follow-up emails to clients ensuring documents are issued in a timely manner to support testing and lot release- Issued Validation documents, Quality Control Qualification documents, Study documents, Batch Records, SOPs, logbooks, and laboratory notebooks for use in GMP production and testing activities- Ensured proper maintenance of document master copies and original production records for both paper and… Show more - Worked with clients and sent documents for review and approval- Sent follow-up emails to clients ensuring documents are issued in a timely manner to support testing and lot release- Issued Validation documents, Quality Control Qualification documents, Study documents, Batch Records, SOPs, logbooks, and laboratory notebooks for use in GMP production and testing activities- Ensured proper maintenance of document master copies and original production records for both paper and electronic systems - Managed the document archival process for off-site storage- Wrote deviations for Document Control- Provided assistance for Regulatory inspections Show less

San Diego, California

- Worked with clients and sent documents for review and approval- Sent follow-up emails to clients ensuring documents are issued in a timely manner to support testing and lot release- Issued Validation documents, Quality Control Qualification documents, Study documents, Batch Records, SOPs, logbooks, and laboratory notebooks for use in GMP production and testing activities- Ensured proper maintenance of document master copies and original production records for both paper and… Show more - Worked with clients and sent documents for review and approval- Sent follow-up emails to clients ensuring documents are issued in a timely manner to support testing and lot release- Issued Validation documents, Quality Control Qualification documents, Study documents, Batch Records, SOPs, logbooks, and laboratory notebooks for use in GMP production and testing activities- Ensured proper maintenance of document master copies and original production records for both paper and electronic systems - Managed the document archival process for off-site storage- Wrote deviations for Document Control- Provided assistance for Regulatory inspections Show less

San Diego, California

- Issued Batch Records, Forms, SOPs, and Validation documents- Developed logs for tracking CAPAs, Deviations, and Internal/External Audits- Managed and maintained all paper and electronic Personnel Training Records and Plans- Provided support in Internal/External audits

San Diego, California

- Performed QA on-the-floor review for production activities- Reviewed Batch Records and other Manufacturing data for product release- Conducted QA product release and coordinated with Inventory- Facilitated initiation, review, and closure of CAPAs and Deviations- Revised and reviewed SOPs, Forms, Protocols, and other controlled documents- Completed periodic review of controlled documents- Reported Quality Metrics for Management Review- Developed logs for tracking… Show more - Performed QA on-the-floor review for production activities- Reviewed Batch Records and other Manufacturing data for product release- Conducted QA product release and coordinated with Inventory- Facilitated initiation, review, and closure of CAPAs and Deviations- Revised and reviewed SOPs, Forms, Protocols, and other controlled documents- Completed periodic review of controlled documents- Reported Quality Metrics for Management Review- Developed logs for tracking CAPAs, Deviations, and Internal/External Audits- Provided support in Internal/External audits Show less

San Diego, California

- Scanned Clinical Documents and Guidance Standards- Ensured documents adhered to document and change management policies, including templates, version control and communication of new/revised documents- Formatted document forms and templates to restrict editing- Managed filing system and computer database for all controlled documents- Maintained Document and Part Number Master List to ensure proper document identification

Greater San Diego Area

- Documented wait times to improve efficiency of handing out prescriptions- Filed and organized pharmacy labels by chronological order- Greeted patients and provided assistance around the hospital- Prepared evaluation sheets for ePIMS and distributed them

Greater San Diego Area

- Answered technical questions about various biochemical products- Maintained chemicals and supplies list for the lab- Managed and organized product COAs and MSDS files in company database - Updated company website and social media platforms- Distributed email newsletters to inform customers about promotions and sales

Biochemistry

Bachelor’S Degree, Pharmacological Chemistry