Get Our FREE Industry eNewsletter

Analyst / Sr Analyst , QC

Grifols Diagnostic Solutions

Apply
Location:
Emeryville, CA
Posted Date:
7/11/2014
Position Type:
Full time
Job Code:
2014-14995
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analyst, QC, Quality, Quality Control,

Job Description

Overview:
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

Requirements

Requirements:
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.

By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.