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Grifols Shared Services North America, Inc Bulk Formulation Chemist II in San Diego, California

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

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.

Primary responsibilities for role:

  • 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.

  • May be working on processes and observed during audits, including ISO, FDA and internal audits.

  • Open and close work orders.

  • Responsible for maintaining laboratory environment in one functional area.

  • Act as material transfer coordinator.

  • Proactively identify operational problems that could lead to scheduling and out-put 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.

Additional Responsibilities:

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.

Knowledge, Skills, and Abilities:

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.

Education:

Typically requires High school Diploma or Associate's (AA) or Bachelor's degree in Microbiology, Biology, Chemistry, Chemical Engineering or related field.

Experience:

4 to 6 years experience in a laboratory or commercial manufacturing setting with a High School Diploma.

2 to 4 years of related experience in a laboratory or commercial manufacturing setting with an Associate’s degree

1 to 3 years of related experience in a laboratory setting with a Bachelor’s degree

At least 1 year of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Example: If a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.

Occupational Demands:

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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 perform reaching, bending, stooping or kneeling motions. Operators may be required to walk and stand for a considerable amount of time. Operators frequently use hands/fingers to handle or feel, open tightly sealed containers/tanks, and utilize hand tools. Operator will occasionally climb step stools/ladders as needed. May frequently or continuously lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight. May occasionally lift, carry, push, pull or otherwise manipulate objects up to 50 pounds in weight. May move heavier (greater than 50lbs) objects and/or materials using carts or pallet jacks.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 427213

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