Production Chemist - Bulk
San Diego Metro Area, CA
Responsible for the manufacture of bulk clinical and commercial kit reagents.
Responsible for sub-assembly formulation, raw material prep and/or processing, QC testing reagent or component formulation and some in-process testing.
Participate in transfer, support activities and continuous improvement on existing processes.
May be assigned to one or more functional Manufacturing areas.
Responsible for the staging of raw materials and formulation of reagent bulks or constituents.
Maintains, measures and dispenses materials
Operates CIP and/or autoclave systems
Performing Enterprise Resource Planning (ERP) transactions
Performing regular cycle count activities to maintain inventory accuracy
Verify materials for manufacturing work orders
Maintains accurate and complete training records
General manufacturing area housekeeping including cleaning of labware, equipment, shelves, benches and sinks and removing trash
Maintain detailed and accurate device history records and log books using Good Documentation Practices
Understands and executes written procedures in accordance with Current Good Manufacturing Practices (cGMP)
Basic to Intermediate level experience in the set-up and operation of reagent bulk tanks and mixers
Intermediate knowledge in the operation of analytical balances, pipettes, filter integrity testers, peristaltic pumps, water baths and spectrophotometers
Completes and forwards device history records for review in a timely manner
Basic to Intermediate-level knowledge on the operation of complex laboratory equipment and processes.
Performs material handling and staging of materials for process orders
Receives and verifies the accuracy of materials transferred from the Warehouse
Perform material and labor transactions in the Enterprise Resource Planning (ERP) System
May be responsible for flushing water ports and eyewash stations
Performs refrigerator/freezer maintenance
Responsible for maintaining laboratory environment in one functional area
Perform general equipment maintenance, operation and calibration
Open and close work orders
Recommends improvements and revisions to device master records & Standard Operating Procedures (SOPs)
Assists Oligo Synthesis Operations as needed
Assist in the training of new chemists
Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.
Follows all safety rules
Adhere to target manufacturing timelines
Must be able to communicate product issues, safety incidences and/or personal issues affecting availability
Punctuality and attendance
Attentiveness and openness to learn new processes
Prior experience with Good Documentation Practices (GDP)
Working knowledge of Microbiology, Biology or Chemistry
Working knowledge of laboratory science, procedures, techniques, instruments & equipment
Working knowledge of general laboratory safety and record keeping
Prior experience in a Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations
Blood Borne Pathogen training
Basic to Intermediate-level knowledge of ERP systems
Ability to follow oral and written instructions
Working knowledge of Microsoft Office software
Good organizational skills
Attention to detail
Repetitive standing, walking, bending and lifting up to 25 lbs.
Strong mathematical skills required
The physical demands:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Visually inspect components and final kits for compliance and specifications.
Close vision (20 inches or less) will be utilized and some color identification will be required.
Frequently required to stand, sit, use hands/fingers to handle or feel, perform reaching, bending, stooping or kneeling motions, and talk or hear.
Operators may be required to walk for a considerable amount of time.
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10-25 pounds in weight, frequently or continuously.
May move objects and/or materials using carts or pallet jacks.
Typically requires a high school diploma, Associate s degree or Bachelor s degree
4 to 6 years of related experience with high school diploma
2 to 4 years of related experience with an Associate s degree
0 to 2 years of related experience with a Bachelor s degree