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Scientific. Clinical. Software Engineering

Production Chemist - Bulk

San Diego Metro Area, CA

Job Type: Scientific Job Number: JN -052020-26794 Region: San Diego Metro Area

Job Description

Duties:

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


Skills:

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

Team-oriented

OCCUPATIONAL DEMANDS:

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.

Education:

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


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