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Grifols Shared Services North America, Inc Mfg Process Technician IV/Lead in San Diego, California

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Summary:

Responsible for performing manufacturing and assembly of clinical and commercial products. Weighs, measures, and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities.

Primary responsibilities for role:

  • Follows all safety rules.

  • Maintains accurate and complete training records.

  • Understands and executes written procedures in accordance with cGMP.

  • Operates basic filling equipment

  • Maintains detailed and accurate device history records

  • Completes and forwards devise history records for review in a timely manner.

  • Operates pipetman.

  • Stocks manufacturing area with supplies.

  • Cleans manufacturing areas, to include lab ware, storage totes, equipment, shelves, benches and sinks and removes trash.

  • Operates Luminometer.

Additional Responsibilities:

  • Assists with material handling and staging of materials for process orders.

  • Receives and verifies the accuracy of materials transferred from the Warehouse; may perform material and labor transactions in the ERP System; may be responsible for flushing water ports and eyewash stations; applies labels according to SOP’s and performs refrigerator/freezer maintenance.

  • Responsible for maintaining laboratory environment in one functional area (multiple filling and/or bulking stations).

  • Maintain laboratory and laboratory stock.

  • Perform general lab audits to ensure compliance with current GMPs and regulations.

  • Perform equipment maintenance.

  • Open and close work orders; ensure ERP transactions are performed in a timely and accurate manner to ensure inventory accuracy.

  • Assist in the preparation of device master records & SOPs.

  • Train new lab personnel.

  • Formulation of subassembly solutions and small reagent bulks.

  • Responsible for decontamination, transportation, handling, and disposal of chemicals and biological waste (human serum).

  • Performs operation/calibration of all general lab equipment.

  • Acts as a Lead Filling Technician, leading daily production processes and ensuring all activities are completed in compliance with current GMPs and regulations.

  • Oversee operations and coordinate production activities in specific filling stations.

  • Assist with scheduling activities.

  • Assist supervisor in mentoring and guiding junior personnel.

  • Work with other departments to help resolve any issues that might delay manufacturing activities.

  • May assist biological safety officer as required.

  • May assist with formulation of large and complex reagents.

  • Revise records and SOPs.

  • May represent manufacturing in meetings and projects.

Knowledge, Skills, and Abilities:

  • Working knowledge of microbiology, chemistry, laboratory safety, recordkeeping and mathematics.

  • Working knowledge of laboratory science, procedures, techniques, instruments & equipment.

  • Working knowledge of general laboratory safety and record keeping. Knowledge of current GMP’s. Blood Borne Pathogen training.

  • Basic computer knowledge.

  • Able to work in BSL-3 structured environment, for the growth of potentially pathogenic organisma or infectious materials.

  • Knowledge of sterilization techniques, solutions and media preparation.

  • General understanding of inventory control and material handling.

Education:

Typically requires High school or AA or BS

Experience:

Typically requires High school and 4-6 years related experience or AA and 2-4 year related experience or BS and 0-2 years related experience

Occupational Demands:

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

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: 217471

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