Inspection Supervisor (2nd Shift) 9/16/2016

Ajinomoto Althea, Inc. San Diego, CA

Company
Ajinomoto Althea, Inc.
Job Classification
Full Time
Company Ref #
360969
AJE Ref #
576197407
Location
San Diego, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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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.

Ajinomoto Althea is currently seeking a 2nd Shift Supervisor, Inspection (Fill Finish Manufacturing) responsible for the implementation of all production and manufacturing procedures to optimize processes and regulatory requirements. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

Althea s 2nd Shift runs from 3:00 pm to 11:30 pm, Monday-Friday. As part of the training process, this candidate will need to have the flexibility to work 1st shift for the first 6 months.

Responsibilities:
Oversees and schedules production operations and personnel within cGMP guidelines.
Interacts and communicates with clients regarding production. Troubleshoots complex manufacturing process problems and issues.
Coordinates with multiple departments including sales and quality on production deliverables.
Trains employees in production methods, cGMP guidelines, and SOP s.
Orders raw materials.
Writes batch records and writes/revises SOP s pertaining to production processes.
Drafts, reviews, revises, and executes batch records, validation protocols, and reports.
Analyzes data and results and provides conclusions and proposals.
Researches and implements new methods and technologies to enhance operations.
Develops scalable processes with improved product yield and reduced costs for manufacturing systems.
Responsible for maintenance of production equipment.
Operates production equipment and may inspect, label, or package.
Collects and disposes of lab wastes according to established procedures.
Embodies Althea s cultural values and aligns daily actions with department goals and company culture.