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Manufacturing - Processing Operator

Company: Global Pharmatek
Location: Irvine
Posted on: November 25, 2022

Job Description:

Job Description: Job Summary

Performs drug product formulation, filling, crimping, sterilization, Visual inspection, labeling and Packaging. May be required to perform all or a combination of the duties listed below.

Principal Duties and Responsibilities:
Buffered solution preparations according to Standard Operating Procedures (SOP s)
Chemical Reactions and RODI Purification of reaction precipitate
Lyophilization and high temperature Calcination of harvested precipitate
Mechanical Bonding of Nanocrystalline Calcium Phosphate Bone Substitute Material
Packaging and assembly of clinical and commercial implantable orthopedic
surgical medical device products
Shipping procedures and documentation, good written and verbal communication skills
Maintain records and clean room environment to comply with regulatory requirements
Handling Demineralized Bone (Human Tissue), all training must stay current
Cross train in all Manufacturing Processes
May be required to perform some of the following: Nitrogen tank replacement and inventory management, assist in quality process document revisions, manufacturing supply ordering and inventory maintenance levels.
Moderate exposure to areas that require understanding of SDS & use of PPE to ensure safety
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence (i.e., knowledge, skills and abilities)
" Ability to recognize deviation from accepted practice record keeping
" Knowledge of scientific equipment, and operation of manufacturing process equipment
" Execution of development and validation protocols for process changes
" Environmental monitoring of manufacturing environments
" Inventory cycle counting, First-In/First-Out (FIFO) methodology
" Proper and safe handling of all wastes considered to be hazardous
" Ability to work in ISO classified clean rooms / environments with appropriate required PPE.
" Ability to work flexible hours. May require standing for prolonged periods.

Education/Experience Requirements

High School diploma with 0-2 years experience or Biotech/Biomed Certificate Program or Associates Degree with 0-2 years experience or equivalent combination of education and experience.
Some knowledge of cGMP s, basic chemistry and experience or training in an FDA regulated environment is desirable but not required

Travel Requirements
None

Keywords: Global Pharmatek, Irvine , Manufacturing - Processing Operator, Other , Irvine, California

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