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 (SOPs) 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
Expected Areas of Competence 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 2-4 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 cGMPs, basic chemistry and experience or training in an FDA regulated environment is desirable but not required
Travel Requirements 0%
Associated topics: bio, biochemistry, bioengineering, biophysics, medical, metabolic, msat, neuro, neuroscience, pharmaceutical
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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