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.

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.

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.

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.

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.

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.

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.

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.

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.