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Miles
Km80.5

Senior Manufacturing Associate

La Jolla Biologics

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Location: San Diego, CA Posted Date: 4/26/2013 Position Type: Full time Job Code: 2013-009 Required Education: Bachelors Degree Areas of Expertise Desired: Laboratory
Manufacturing/Production

Description

Summary

As a member of the manufacturing team, the Senior Manufacturing Associate will be primarily responsible for participating in aseptic filling operations.

Job Responsibilities

Essential
?   With minimal supervision prepare equipment and materials for production and maintain manufacturing material inventory.
?   Operating general manufacturing equipment such as autoclaves, washers and automated aseptic filling equipment.
?   Assist with training and supervising other staff in filling operations as directed.
?   Preparing, reviewing and completing cGMP documentation.
?   Communicating with management, Quality, Facility and Engineering staff regarding status of manufacturing operations.
?   Participate in process investigations, deviations, corrective actions.
?   Troubleshooting equipment and process.
?   Support process improvement and expansion efforts.
?   Assist with bulk manufacturing, as needed.
?   Maintaining the highest cGMP compliance and inspection readiness.

Requirements

Education and Experience
?   BS/BA degree strongly preferred. Associates degree and High School Diploma acceptable with related experience or training.
?   3 - 5 years of experience with Bachelors, 4 - 6 years of experience with Associates, 7 - 9 years with High School Diploma.
?   Sterile filling experience required; experience with aseptic processing and aseptic gowning in the bio/pharmaceutical industry preferred.

Knowledge, skills and abilities
?   Accurate attention to detail, experience with cGMP documentation and a broad understanding of pharmaceutical production is required.
?   Good organizational skills.
?   Strong verbal and written communication skills.
?   Experience working in a team based organization.
?   Must be flexible to work a flexible schedule with varying hours.


Work Environment/Physical Demands/Safety Considerations

?   Standard office environment
?   Standard Lab environment
?   Clinical manufacturing environment
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