Biomat USA, Inc. QA Inspector in Los Angeles, 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.
Monday - Friday 8:00am - 4:30pm
Quality Assurance Inspectors work with manufacturing operations during the production process, by approving the raw materials and associated documentation for incoming plasma shipments from donor collection centers, in-process production batches (Production Units - PUs), and the final plasma Lot shipment for distribution and sales at the Plasma Logistics Center (GPLCW). Quality Assurance Inspectors identifies and document deviations of both materials and the manufacturing process and ensure these deviations are corrected to ensure a better finished product for prospective customers.
Approves incoming plasma shipment documentation and raw materials by confirming specifications, rejects and returns unacceptable materials as directed by QA Supervisor.
Monitors the quality of the production operation by constantly auditing the production process to ensure compliance with customer specifications and GPLCW standard operating procedures.
Generates and documents non-conformance of plasma units rejected from plasma shipments, in process batches or final plasma Lots.
Approves in-process plasma batches (Pus) and final plasma lot shipments by confirming customer and regulatory specifications and communicating required adjustments to the QA Supervisor.
Responsible for inspecting final outgoing plasma lot shipments to ensure all pallets are properly packaged and loaded for sales and distribution.
Investigates and reports in-process/final product and processes that do not meet quality specifications and document in a deviation report.
Participates in the writing or revision of policies and standard operating procedures related to Source Plasma and quality systems at GPLCW.
Executes repetitive functions with strict adherence to procedures and maintains record accountability
Documents approval activities in the organizations computer system (Plasma Management System- SGP) to maintain accurate records
Experience and Education
High School diploma or GED.
Typically requires a minimum of 1 year of Quality Assurance related experience and 2 years working in pharmaceuticals. Experience in the pharmaceutical, plasma/blood banking or medical device industry is ideal and working knowledge of cGMP helpful.
Good communication skills with the ability to express ideas with clarity and thoroughness in both verbal and written communications. Proactive, results oriented with a strong attention to detail. Strong interpersonal skills to interface with manufacturing operators and various levels of management as well as with support and service departments. Ability to work in a team-oriented environment and follow safety guidelines. Must be computer literate with experience in the use of Microsoft applications. Able to perform basic arithmetic functions including addition, subtraction, multiplication, division and using decimals.
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.
Learn more about Grifols
Req ID: 291153
Type: Regular Full-Time
Job Category: Quality