Grifols Veterans Jobs

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Grifols Shared Services North America, Inc Manufacturing Process Technician III 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. Participates in the filling, aliquoting, and packaging of bulk material into the final product.

Primary responsibilities for role:

  • Follows all safety rules.

  • 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.

  • Stocks manufacturing area with supplies.

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

  • Handling and traying of temperature-sensitive (semi) finished goods for use in blood screening kits

  • Perform in process visual inspection of temperature-sensitive (semi) finished goods for use in blood screening kits as they come off the fill line before placement in trays

  • Perform sample gathering of temperature-sensitive (semi) finish good for use in blood screening kits for QC and Bio-burden

  • Receives and verifies the accuracy of materials transferred from the warehouse.

  • Understands and executes written procedures in accordance with cGMP.

  • Performs labor transactions in the Enterprise Resource Planning (ERP) System.

  • Demonstrate processes during audits, including ISO, FDA and internal audits.

  • Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines.

  • Independently perform and lead the set-up and operation of reagent filling equipment of at least 70% of automated fill machines

  • Performs material and labor transactions in the Enterprise Resource Planning (ERP) System.

  • Perform equipment troubleshooting during operation to ensure completion within the scheduled time frame

  • Assist with training and mentoring Manufacturing Process Technician I and Manufacturing Process Technician II

  • Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation

Additional Responsibilities:

  • Assist with Device History Record (DHR) review.

  • May be responsible for demonstrating manufacturing processes during a customer or regulatory audit.

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

  • Performs Operation/calibration lab equipment

Knowledge, Skills, and Abilities:

  • Demonstrated job specific technical knowledge.

  • Intermediate knowledge of laboratory safety and record keeping.

  • Working knowledge of GDP, GMP and ISO Reg. Blood Borne Pathogen Training.

  • Advanced knowledge of Microsoft Office software.

  • Attention to detail, good organizational skills and team oriented.

  • Ability to follow oral and written instructions.

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

  • Ability to effectively communicate with team members and cross-functional departments.

Education:

  • Requires High School Diploma, GED or Associates Degree in Biology, Mechanics, Engineering or related field desired.

Experience:

  • 4 years minimum experience as a reagent fill technician or equivalent in a regulated setting.

  • Prior experience troubleshooting fill equipment.

  • 4-5 years minimum experience in a lab setting is highly preferred.

  • Mechanics certification desired.

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: 214897

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