Sr. Technical Writer II Investigations – QC Chemistry - San Diego, CA | Biospace
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Sr. Technical Writer II Investigations – QC Chemistry

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
2/2/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

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.

In conjunction with drug product 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.



Ajinomoto Althea is currently seeking a Sr. Technical Writer II Investigations – QC Chemistry to serve as the department SME for investigations including deviations, out-of-specification investigations, and corrective and preventive actions. You will be an invaluable addition to our QC team, responsible for the technical writing tied to the various investigation activities as well as the review of associated GMP documents.



Responsibilities:
•Develops technically justified recommendations and resolutions to investigation conclusions and ensures timely completion of reports, corrective actions and associated activities.
•Evaluates the effectiveness of investigations and action plans.
•Identifies system level gaps and facilitates process improvements.
•Serves as department SME for technical writing.
•Reviews and approves lot specific chemistry testing data for accuracy and initiate corrective action where required.
•Assists in the preparation and review of validation protocols/reports.
•Trains junior team members on technical writing.
•Reviews data obtained for compliance to specifications and reports abnormalities to supervisor.
•Initiates revisions to current SOPs. Prepares SOPs for approval.
•Generates and evaluates department metrics/data for trends for management review.
•Participates in internal and client audits as needed.
•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

•Bachelor’s degree required in a Life Sciences discipline or equivalent.
•Minimum of four (4) years of experience writing and performing investigations in Quality.
•Minimum of eight (8) years of relevant experience in Quality Control laboratory.
•Experience with GMP and troubleshooting.
•Proficiency with Microsoft Office applications.
•Detail oriented with very strong written and verbal communication skills.
•Ability to work independently, within prescribed guidelines, or as a team member.

Ajinomoto Althea, Inc., located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early- stage and commercial requirements.



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.