ROCHELLE B. ESPINOSA

Lathrop, CA, ***** 510-***-**** ac8ope@r.postjobfree.com linked.com/in/rrb1021

QUALITY ASSURANCE

Quality Assurance Associate that performs quality procedures designed to ensure production of commercial products in compliance and consistent with established policies. Exceedingly detail oriented and has the ability to meet stringent cGMP, FDA and regulatory requirements, works with urgency and with strong analytical and problem-solving skills. Other skills include:

Proficient in Microsoft Word, Excel and Outlook.

Knowledgeable of delivering timely project deliverables.

Strong working knowledge of FDA, GMP, GDP and Quality Systems.

Knowledgeable in collating Manufacturing and Packaging Batch Records issuance processes from VEEVA Vault, TrackWise updating Access, SAP and gLims database.

Use of SAP, TrackWise, gLims and Box to input and extract information.

EXPERIENCE

Amneal Pharmaceuticals Company (Formerly Impax Laboratories, LLC) 2006-2018

Associate I, Quality Assurance Product Release Group 2016-2018

Ensure compliance though audits, training data and document reviews, and analysis.

Collated Manufacturing and Packaging Batch Records Issuance processes from VEEVA Vault, TrackWise, updating Access, SAP and gLIMS databases that ensured timely manufacture.

Issues, reviews and organized batch production records for machinability and demo runs for clients and products.

Complete Certificate of Conformance (COC), Certificate of Manufacture (COfM) and transcribe Certificate of Analysis (COA).

Complete Shipping documents to transfer bulk products to packaging Facility.

Generate Deviation Reports using TrackWise and assist Quality Engineers with investigations.

Initiates Hold Notifications / NCR (Non-Conformance Report) and collaborates with Quality Engineers to initiate Corrective and Preventative Actions (CAPA).

Collate quality related data for trending and further analysis.

Issue and reject raw materials, work in progress and finished products based on project record disposition.

Use SAP, TrackWise, Box and gLIMS to input and extract information.

Generate Logbooks, Investigation Reports and Notice of Incident Reports.

Provide quality assurance floor support for operations as a Quality Assurance Inspector.

Perform AQL attribute sampling inspection of finished products and tighten quality inspections, as necessary.

Review quality procedures, batch records, in-process test results and AQL attribute inspectors.

Coordinate with the launch of new product as a QA Product Release Associate.

Manufacturing Technician I, II and III 2006-2016

Independently performs complex tasks to support solid oral dose commercial manufacturing activities in the Production facility.

Operates and maintains solid oral dose production equipment which may include; Tablet compression, Encapsulation and Coating.

Maintain documentation in compliance with current Good Manufacturing Practices (cGMP).

Perform set-up, operation, troubleshoot, dismantle and clean a broad range of solid oral dose equipment (e.g. tablet compression encapsulation and coating) used in the manufacturing of commercial product.

Monitor product and process parameters throughout the process and perform in-process sampling and or testing as required.

Assist with the updating and revision of commercial operational and cleaning SOP’s and related documentation.

Assisted validation team with operation of equipment during qualification of new equipment and component qualification activities.

Contributed to daily operations of fulfillment of manufacturing products.

Interact with R&D and Technical Services to provide operational and technical expertise in the execution of the experimental and pivotal batches, Process Performance Qualifications (PPQ) and process validation operations.

Provide on-the-job and procedural training to other Technicians.

Acted as a subject matter expert (SME) for qualified encapsulation, compression, coating and imprinting machines for oral solid dosage pharmaceuticals.

Qualified as a SOJT trainer.

Qualified to set-up, disassemble, clean and operate the following machines for Coating, Imprinting, Capsule Checkweigher, Encapsulation and Compression; Kikusui Libra II, Harnett Imprinter, Bosch Checkweigher, MG2 Planeta Encapsulator, Fetti 2200i and Fetti 1200i, MET 30+ Metal Detector, Pharma Technology Combi 500 LI Tablet Deduster, IMA Capsule Sorter, Capsule Polisher, 48” and 60” Accela Cota, Portable Solution Mixer and Coater Spray Guns.

EDUCATION

Bachelor of Science Pharmacy,

Centro Escolar University, Manila Philippines

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