Supervisor, Visual Inspection (Fill Finish Manufacturing) - San Diego, CA | Biospace
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Supervisor, Visual Inspection (Fill Finish Manufacturing)

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
2/15/2017
Position Type:
Full time
Job Code:
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Manufacturing, Manufacturing/Production,

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.



Ajinomoto Althea is currently seeking a Supervisor, Visual Inspection (Fill Finish Manufacturing). This position is responsible for implementation of all production and manufacturing procedures as they relate to inspection operations to optimize processes and comply with regulatory requirements. You will be responsible for collaborations related to new technologies, particulate and glass defect analyses and will assist in investigations. The Supervisor works closely with other departments such as Investigations, QC Raw Materials, AQL Inspection, and Fill Finish Manufacturing.



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.
•Oversees compliance to visual inspection procedures within cGMP guidelines.
•Interacts with clients, investigations, Manufacturing, QC and QA to assure successful technical transfer and integration of visual inspection processes into the manufacturing department.
•Serves as technical SME during interactions and communications with internal and external client stakeholders regarding production.
•Interacts with potential clients, client auditors and regulatory bodies as subject matter expert.
•Analyzes and trends data and results and provides conclusions and proposals.
•Supports troubleshooting manufacturing process problems.
•Employs high level technical expertise to develop new processes and creatively solve problems.
•Writes/executes inspection protocols, SOPs, forms, and study reports.
•Responsible for coordinating guest speakers and seminars, and ongoing employee training/education.
•Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.

Requirements

Requirements:
•Bachelor’s degree in a Life Sciences discipline or equivalent training and experience required.
•Minimum of five (5) years of relevant experience in a manufacturing or laboratory environment.
•Minimum of three (3) years of experience in Visual Inspection of pharmaceutical products
•Minimum of one to three (1-3) years of leadership/supervisory experience.
•Experience with analytical methods such as SEM/EDS, microscopy and fractography is a plus.
•Strong knowledge of automated and manual inspection techniques.
•Experience with cGMP, manufacturing, machine operations, and data entry.
•Ability to work independently, within prescribed guidelines, or as a team member.
•Demonstrated ability to follow detailed directions in a laboratory environment.
•Knowledge of Lean Manufacturing techniques desirable.
•Detail oriented with strong verbal and written communication skills.
•Proficiency with Microsoft Office applications.

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.