Bulk Formulation Chemist I

GRIFOLS, S.A.•San Diego, CA

1d•$24 - $30•Onsite

About The Position

Grifols Diagnostics Solutions is seeking a Bulk Formulation Chemist I in San Diego, CA. This position is 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. In order to be successful in this position, we are looking for at least a Bachelors Degree in Microbiology, Biology, Chemistry, Chemical Engineering or related field.

Requirements

Demonstrated job specific technical knowledge.
Working knowledge of Microbiology, Biology, or Chemistry.
Working knowledge of laboratory safety and record keeping.
Blood Borne Pathogen Training.
Basic to intermediate knowledge in the operation of analytical balances, pipettes, filter integrity testers, peristaltic pumps, water baths and spectrophotometers.
Basic to intermediate-level knowledge on the operation of complex laboratory equipment and processes.
Working knowledge of Microsoft Office software.
Attention to detail and ability maintain accurate inventory accounts, good organizational skills and team oriented.
Ability to follow oral and written instructions
At least 1 year of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is highly preferred

Nice To Haves

Bachelors Degree in Microbiology, Biology, Chemistry, Chemical Engineering or related field.

Responsibilities

Responsible for the staging of raw material and formulation of reagent bulks or constituents.
Maintains, measures and dispenses materials.
Performs material and labor transactions in the Enterprise Resource Planning (ERP) System.
Understands and executes written procedures in accordance with cGMP.
Maintains detailed and accurate device history records with cGMP.
Completes and forwards device history records for review in a timely manner.
General manufacturing area housekeeping including cleaning of labware, equipment, shelves, benches and sinks and removing trash.
Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.
Operates and calibrates as needed all general lab equipment.
Follows all safety rules.
Maintains accurate and complete training records.
Maintains and archives Manufacturing log sheet records.
Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines.
Performs regular cycle count activities to maintain inventory accuracy.
May be working on processes and observed during audits, including ISO, FDA and internal audits.
Participates in continuous improvement projects.
Cross-functional communication participation.
Assists fill crew as needed.
Responsible for flushing water ports and eyewash stations.
Adhere to target manufacturing timelines.
Attentiveness and openness to learn new processes.
Maintains implemented 5S.