Jessica Lower Email & Phone Number

Redondo Beach, Ca, Us

Torrance, California, United States

- Reviewed batch documentation and QC data to ensure timely release of Certificate of Analysis by resolving issues and maintaining compliance with standards and regulations.- Performed risk assessments on change controls and deviations with customer notification as needed.- Final QA reviewed QC stability protocols, sampling plans, stability data and released stability reports.- Led the initiation and resolution of Corrective and Preventive Actions (CAPAs) to prevent quality issues.- Developed and updated procedures, forms, and documentation to support quality assurance.- Scribed and provided support within front room of FDA audit.- Released raw materials for production use.- Make sure all raw materials and vendors are qualified before release.- Perform material / vendor qualification if needed.- Created tracking logs between departments for more efficient communication and clarity.- Review raw material change controls for compliance and completeness

Torrance, California, United States

- Implemented global supplier, manufacturer, material, GMP services, and contract lab qualification procedures at US sites.- Sent questionnaires to vendors and requested documentation on materials.- Assessed questionnaires received from suppliers and manufacturers.- Worked closely with all departments involved in the qualification process.- Coordinated meetings for involved departments to promote open communication and work through issues.- Raw material release, which includes reviewing QC data, making sure all forms are filled out correctly, making sure vendors and raw materials are qualified before releasing them for use.- Performed gap assessment from previous qualification procedures to the new process.- Performed all responsibilities from Neoantigen Team Lead QC role as well.

Torrance, California, United States

• Led a team of up to 4 chemists to oversee and execute all QC testing for up to 6 Neoantigen projects and releasing approximately 50 sample lots on time.• Coordinated with Quality Control, Production, Validation, Quality Assurance, Project Management, Sales departments, and outside laboratories to achieve company goals.• Developed presentations, introduced effective resolutions, and collaborated with pharmaceutical companies to exceed customer satisfaction.• Oversaw completion of QC action items and communicated timelines while using various project management software such as Smartsheet to effectively keep track of activities.• Improved the operating efficiency of the QC department by implementing sample submission form, sample tracking form, checklist for failing peptides, and provided effective personnel training.• Performed internal quality assessments of IPC and QC data to provide feedback and facilitate team collaboration to improve Polypeptide’s overall success rates.• Escalated non-compliances by initiating OOS, OOE, or deviations and developed corrective actions and preventative actions to assist in our overall success as a team.• Generated stability reports, specifications, SOPs, change controls, and OOS reports.• Created stability protocols, stability pull calendars and stability reports, which included trending stability data.• Was responsible to place stability samples in stability chambers with QA department and communicate with QC chemists of the upcoming stability timepoints.• Reviewed QC chemist’s analyses for compliance and prepared QC standard CoAs.QC Chemist II* Represented the QC department for up to 14 projects concurrently by creating meeting minutes, communicating action items to the team while overseeing the execution of tasks in a timely manner.* Lead a project to optimize efficiency in QC by the organization of reference standard CoAs, dispensing logs, and storage locations.

Los Angeles, California, United States

Responsible to start up remediation department. Installed all instrumentation: CPC, HPLC and rotary evaporators.Performed method development on Gilson CPC instrumentation.Used rotary evaporators to recover methanol, water, heptane and pentane from product.Created SOPs, checklists, training logs, CAPA form, deviation form, change request form, GxP rules, end of day reports for production manager, procurement lists with pricing for remediation area needs, maintenance logs, etc.Send samples to outside testing laboratories, keep clear / open communication with laboratories, track and organize all CoAs.Trained and managed two employees to remediate distillate with a Gilson CPC instrument and perform all solvent recovery.Was trained on Buchi equipment for THC remediation and also Interchim equipment for pesticide remediation.

Los Angeles, California

Equipment: LC/TQ, GC/TQ, HPLC, GC/FIDSoftware: MassHunter, OpenLab, LablynxValidation experience for BCC and ISO.ISO accreditation in the cannabis industry with 2 other employees in a start-up laboratory.Performed method development and method validation on testing methods for GCMS FID, GCMS TQ, LCMS TQ, ICP-MS and HPLC instrumentation.Created SOPs and work instructions for validated methods.Created quality assurance documents for employee training, GxP guidelines, raw data reviews and instrument calibration.Performed quality control testing on cannabis products for research and development.Correlated with expert contacts to help with method and instrumentation issues.Fully maintained laboratory including inventory, cleanliness, safety, maintenance and workflow.Trained analysts on equipment and testing methods.

Chatsworth, California

NSF accredidation in the nutraceutical industry with 7 other employees in the laboratory.Performed raw material, in- process and finished product testing with HPLC, GC, ICP-MS, Karl Fischer, and FTIR instrumentation.Developed, validated, wrote SOPs and work instructions for new methods and instruments.Trained, assigned daily tasks and monitored laboratory technicians. Implemented and assigned weekly maintenance, inventory checks, disposal of expired solutions and standards.Chemstation, Microsoft (Word, Exel, PowerPoint and Office), and Chromeleon software experience.

Titusville, New Jersey

Performed routine stability testing on J&J products with HPLC, UHPLC, dissolution baths, pH-meters, titrators and Karl-Fischer.Trended data and reviewed chemists’ notebooks.Trained new employees on qualified projects successfully. Empower 3.0 software experience.eLIMS, ComplianceWire, Smart-QC, Sharepoint, SUMMIT, Docspace, Tackwise, and Microsoft (Word, Excel, Powerpoint and Outlook) software experience.

Frankfurt Am Main Area, Germany

cGMP, FDA, ICH, and VICH in pharmaceutical industry with 30+ employees in the laboratory.Technician for HPLC instruments, subvisible particle tester and osmometer. Performed validation, transfer projects along with stability testing and release testing. Experience with data review, testing physical parameters, water content (KF), HPLC (DAD / UV), purity, content, photometer testing, osmolality, pH, titrations, dissolutions, etc. Qualified equipment (DQ, IQ, OQ and PQ)Empower 2.0 software experience.

Kutztown, Pennsylvania

Discovered the quantitative value of Capsaicin permeated through different types of membranes (egg, polysulfone, and pig ear) diffused by a Franz cell. An HPLC was used to analyze the samples.