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Grifols Shared Services North America, Inc QA Specialist II in Emeryville, 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:

The QA Specialist II manages their own activities related to their area of expertise (see Task List for specified activities). Ensures compliance with and demonstrates knowledge of site level policies related to area of expertise.

Primary responsibilities for role:

The specific duties/responsibilities include, but are not limited to:

  • Primary responsibility is to provide QA support on the floor during routine operations in the Manufacturing/QC areas

  • Support Manufacturing activities during scheduled shifts. This may require and include evening/weekend support.

  • Independently and in some cases, with guidance from senior management, provides quality advice to Manufacturing and Quality groups regarding on-going manufacturing and testing.

  • Ensures compliance to documents that govern Manufacturing and Quality operations.

  • Performs an independent quality review of the work performed by Manufacturing and Quality groups. (BPD, TRF, Logbook)

  • Perform minor deviation investigations and follow up to ensure timely resolution or escalation, if deemed necessary during the process of investigation.

  • Reviews minor deviation investigations and coordinates within QA team to ensure closure and disposition of impacted products.

  • Assists with investigations related to suppliers for their designated production area.

  • Troubleshoots problems in their assigned production process unit, identifies and isolates causal factors through effective root cause analysis techniques and proactively innovates new and effective strategies for problem resolution solutions.

  • May interact with regulatory and partner auditors/inspectors during tours.

  • Comply Site Environmental Health & Safety (EH&S) requirements

Knowledge, Skills, and Abilities:

  • Ability to quickly and logically evaluate and solve simple- moderately complex problems daily.

  • Ability to clearly and concisely document results of simple projects, evaluations, or investigations.

  • At least 6 years’ experience in a regulated GMP testing laboratory with a minimum of 4 years in a regulated (GMP/ISO/QSR) industry. QA experience desirable

  • Must have \experience in one or more of the main areas listed:

  • Fermentation processes using E.coli, yeast cell culture or other organisms

  • Analytical testing methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits for the analysis of finished products.

  • Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing that may impact production processes.

  • Manufacture of Bacterial and Yeast Seedstock

  • Environmental/Utility/facility Monitoring programs and impact to production facilities

  • Equipment qualification, calibration and preventative maintenance programs

  • Experience in one or more validation areas: Process, Cleaning, Facilities, Utilities and Equipment validation

  • Strong scientific analytical skills, proficient in MS Word, MS PowerPoint and MS Excel software.

  • Must be familiar with GMP's and Quality System Regulations (QS Regs).

  • Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.

  • Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.

Education:

Bachelor’s Degree, in life or physical sciences.

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 requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a Master’s degree with 2 years of 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: 469628

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