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Analyst / Sr Analyst , QC

Grifols Diagnostic Solutions

Emeryville, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analyst, QC, Quality, Quality Control,

Job Description

This position will be responsible for performing in-process, release and stability assays supporting GMP manufacturing of commercial products, validation testing and R&D testing as needed.

Major Activities:
•   Conduct routine tasks to support the review and release of final product following established procedures.
•   Perform GMP support functions and assays, such as reagent preparation, chemistry assays, protein assays, HPLC, SDS-Page, Western Blots and ELISA’s.
•   Complete all assay method training and assigned testing on schedule and routinely maintain high throughput of analytical assays with accurate, precise, and reproducible results.
•   Initiate Sentry events and assist investigations to identify root cause of non-conformance and implementation of corrective and preventative action plans.
•   Initiate and perform OOS/OOT investigations
•   May interact with other departments (QA, Fac Ops, Manufacturing, Supply Chain) to ensure testing is performed in a timely manner.
•   Legibly document testing results in order to meet regulatory requirements to ensure completeness and accuracy per cGMPs.
•   Perform GMP review of completed QC test report forms.  Ensure that data entry in LIMS database is current for data in scope.
•   Maintain GMP systems supporting routine testing and demonstrate continued adherence to compliance standards defined in cGMP’s
•   Other duties when assigned.

Key Performance Indicators:

•   Consistent levels of performance/productivity, and demonstration of knowledge of relevant product lines and quality systems.
•   Sound decision to ensure no delays in schedules and operations
•   Strong written and verbal communication skills
•   All required trainings are up-to-date


Education (minimum/desirable): BS in Chemistry, Biology or related field, or equivalent combination of education and experience

Experience/Professional requirement:

Analyst:  0 - 3 years with BS in sciences or related field
Senior Analyst: 3 - 10 years with BS in sciences or related field or an MS in sciences or related field with 0 to 3 years experience

Professional Competencies:
•   Highly motivated towards achievement and task oriented.
•   Strong analytical and critical thinking skills.
•   Knowledgeable in protein chemistry techniques such as pH, Lowry Protein Determination, SDS-PAGE, Western Blot, ELISA, HPLC, and reagent preparation.
•   Excellent technical and pipetting skills as well as strong oral and written communication skills.
•   Proficiency in MS Word and MS Excel.
•   Ability to effectively organize and manage personal work schedule independently a must.

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