Sr. QC Associate I - ADC - San Diego, CA | Biospace
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Sr. QC Associate I - ADC

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
9/13/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analytical Chemistry, QA, QC, Quality, Quality Control,

Job Description

Let’s Make Things Happen!



Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.



Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.



Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.



Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.



Althea is currently seeking a Sr. QC Associate I - ADC responsible for providing Quality Control laboratory routine testing support for all process development, in-process, release and stability sample testing associated with development and manufacturing of highly potent products (HPP). Support will be largely focused on biochemical analysis [ELISAs & Westerns], gels, spectroscopy, and compendial methods. Data processing and written records must be kept according to good documentation procedures. This position will be required to operate and maintain instrumentation in the HPP laboratories for which they are trained.



Responsibilities:
•Performs routine QC testing according to Standard Operating Procedures (SOPs) with GDP documentation. Analyzes and processes data using a variety of scientific software.
•Prepares solutions and buffers according to SOPs to support QC operations.
•Responsible for maintenance of laboratory chemical inventory of QC testing materials and supplies. Maintains lab area including cleaning of benches, biosafety cabinets and shelving according to 5S standards.
•Maintains instrumentation according to standard operating procedures.
•Initiates revisions to current SOPs/Protocols/Reports and authors new SOPs/Protocols/Reports with appropriate level of independence.
•Ensures analytical methods have been properly validated/qualified as appropriate in compliance with GMP prior to using the method.
•Recognized at the department level as a subject matter expert in ELISA methodology. Performs, reviews and troubleshoots assays.  
•Participates in regulatory inspections.
•Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
•Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Requirements

Requirements:
•Bachelor’s degree in a Life Sciences discipline or equivalent and minimum of three to five (3-5) years of related experience or Masters in Life Science discipline and a minimum of two (2) years of related experience.
•Minimum of two (2) years of experience performing ELISAs. Some experience performing compendial methods preferred.
•Experience with GMP and FDA regulations required.
•Ability to perform testing in a highly accurate and reproducible manner.
•Effective problem solving/troubleshooting skills.
•Detail oriented with strong written and verbal communication skills.
•Ability to work independently, within prescribed guidelines, or as a team member.
•Demonstrated ability to follow detailed directions in a laboratory environment.
•Proficiency with Softmax Pro, JMP, and/or LIMS preferred.

If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the Careers section.  Please be sure to note where you saw our ad posting.



We are an EOE dedicated to a diverse work force and Drug Free work environment.

Qualified M/F/D/V candidates are encouraged to apply.