Bulk Formulation Chemist II

GRIFOLS, S.A.•San Diego, CA

1d•Onsite

About The Position

Grifols Diagnostic in San Diego, CA is seeking a Bulk Formulation Chemist II. The Bulk Formulation Chemist II will be 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.

Requirements

Individuals with a Bachelor's degree must have 1 to 3 years of related experience in a laboratory setting.
Individuals with an Associate’s degree must have 2 to 4 years of related experience in a laboratory or commercial manufacturing setting.
Individuals with High School diplomas must have at least 4 to 6 years of experience in a laboratory or commercial manufacturing setting.
At least 1 year of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required
Demonstrated job specific technical knowledge.
Working knowledge of Microbiology, Biology, or Chemistry
Working knowledge of laboratory safety and record keeping.
Working knowledge of ERP system.
Working knowledge of GDP, GMP. Blood Borne Pathogen Training.
Intermediate knowledge in the operation of analytical balances, pipettes, filter integrity testers, peristaltic pumps, water baths and spectrophotometers.
Basic level experience in the set-up and operation of reagent bulk tanks and mixers.
Intermediate-level knowledge on the operation of complex laboratory equipment and processes.
Working knowledge of Microsoft Office software.
Attention to detail, good organizational skills and team-oriented.
Ability to follow oral and written instructions.

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 includes cleaning of labware, equipment, shelves, benches and sinks and removing trash.
Ensure 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.
May be working on processes and observed during audits, including ISO, FDA and internal audits.
Open and close work orders.
Responsible for maintaining a laboratory environment in one functional area.
Act as material transfer coordinator.
Proactively identify operational problems that could lead to scheduling and output conflict and potential solutions.
Aid metrology liaison: gather from the lab the equipment due for calibration on a monthly basis.
Verify or perform cycle counts and verify discrepancy, conduct investigation and complete report.
Identify new opportunities for 5S.
Identify and participate in process improvement projects.
QN investigations: provide information to the QN author as needed.
Cross-functional communication participation.
Responsible for flushing water ports and eyewash stations.
Adhere to target manufacturing timelines.
Attentiveness and openness to learn new processes.
Maintains implemented 5S.
Performs refrigerator/freezer maintenance.
Perform general equipment maintenance, operation and calibration.
Assists Oligo Synthesis Operations or Fill team as needed.