Post Job Free
Sign in

Production Operator R D

Location:
Irvine, CA
Posted:
May 24, 2024

Contact this candidate

Resume:

BEN HO

714-***-****

E-mail: ad5xs1@r.postjobfree.com

**** – Current Biduro -Sundia Irvine, CA

Formulation Development Technician

Perform set-up, operation, troubleshoot, dismantle and clean solid oral dose equipment (e.g.: spray dryer, fluid bed technology, roller compaction, granulation, blending, tablet compression, encapsulation and coating) used in the R&D and manufacturing suite.

Complete all documentation required for batch processing in a GMP (Good Manufacturing Practice) compliant manner, including development batch records, process labels, room and equipment logbooks and in-process documentation.

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

Ensure that all pertinent issues are communicated and properly escalated.

Work closely with senior Formulation Scientists and Engineering team in the execution of development batches, prototype manufacturing, lab experiments, lab maintenance and equipment troubleshooting.

2021 – 2023 Bioduro - Sundia Irvine, CA

Production Operator

Operate pharmaceutical production machineries and follow procedures for manufacturing such as pharmacy, Granulation, milling, blending, compression, compounding and coating.

Performing daily procedures, follow all safety, all cGMP, ensure compliance with SOP’s, policies and procedures as required by the company.

2015 – 2021 Endo Pharmaceutical INC Irvine, CA

Production Operator

Operate pharmaceutical production machineries and follow procedures for manufacturing such as pharmacy, Granulation, milling, blending, compression, compounding and coating.

Performing daily procedures, follow all safety, all cGMP, ensure compliance with SOP’s, policies and procedures as required by the company.

2012 – 2015 Endo (PAR) Pharmaceutical INC. Irvine, CA

Development Technician

Support the scientist or formulator process development of different pharmaceutical dosage forms: Blending, Compression, Encapsulation, Granulation, Compounding and Coating.

Work closely with Formulation scientists and engineering team in the execution of development batches, prototype manufacturing, lab experiments, and equipment troubleshooting.

Complete all documentation required for batch processing in GMP compliant manner, including development batch record and in-process documentation.

Set-up and operates different processing equipment.

Performing Cleans and maintains processing rooms and equipment.

Ensures equipment logbooks, room logbooks and batch records are current.

Assists scientist in performing experimental works.

Monitors equipment during processing and make necessary adjustments to maintain batch record specifications.

Follows SOP’s and batch record instructions.

Perform related duties as assigned.

2005 - 2012 Metagenics Inc. San Clemente, CA

Vitamin Supplement/Medical Foods Manufacturing

Quality Control Technician

QC Procedures for Bulk/ Packaging Materials, Finished Goods and packaging components.

Labeling Control Procedure, Labels Revision Control and Labels Lot number assignment.

Reviewed production records to assure material meet specifications.

Reviewed documentation and identifies trends; provides detailed written observations to management as appropriate.

Assisted management with approval or Rejection of components, labeling, in-process material and finished good products.

Assisted management in conducting formal procedural inquiries and investigations to determine cause of quality problems, and recommends verbal and/or written corrective action to management as required.

To initiated control of any non-conforming or suspect product and issue a non-conformance report stating the conditions found to reject or disposition of products.

EDUCATION

Golden West College Huntington Beach, CA

-General Education

Chapman College Garden Grove, CA

- EPA Certified

- Air Conditioning - A/C Certified

- Certificate of Completion of ASQ’s Foundations in Quality Self-Directed Learning program for the Quality 101.

CNC Machinist

-Certified on CNC Mills/Lathes

INTERESTS

Basketball, gardening, movies, and reading



Contact this candidate