Aseptic Shift Team Lead

AbbVie•Waco, TX

20h•Onsite

About The Position

Responsible for the daily coordination of the production activities in the Multi Dose Aseptic area with responsibility to maintain environmental standards established for Multi Dose Aseptic Areas to ensure regulatory compliance in accordance with Good Manufacturing Practices (GMP’s) and department Standard Operating Procedures (SOP’s).

Requirements

High School Diploma or equivalent required.
Minimum of seven (7) years production experience or two (2) years of production experience with prior leadership experience.
Aseptic certification required, or the ability to become aseptic certified.
User knowledge of Microsoft Office is strongly preferred.
User must have a proficiency in SAP transactions.
Working knowledge of cGMP’s and ISO 9002 familiarization and experience working in a GMP regulated environment preferred.
Experience working in an Aseptic Production environment preferred and have met all the requirements of a Tech III.

Nice To Haves

Bachelor’s or Associate’s Degree preferred.
Experience participation in projects a plus.
Bachelor’s Degree accepted in lieu of experience.

Responsibilities

Accountable for assigned production lines Labor Utilization, Material Loss, Safety.
Perform real time document review, facilitate labor by coordinating/ facilitating breaks and line turns, and ensure materials for subsequent batches are available.
Coordinates, writes and/or circulates for approval all documentation applicable to the production of filled products that are manufactured, packaged, tested and inspected in compliance with Standard Operating Procedures and current Good Manufacturing Practices.
Developing trend lines and conducting data analyses of production issues related to effective and efficient operation of production process.
Perform aseptic room sanitization tasks, basic equipment operation, in-process inspections, testing, and cleaning.
Assist in equipment maintenance and repair activities.
Perform line setup and basic troubleshooting of equipment, such as by not limited to: CIP (Clean in Place), SIP (Steam in Place) and Line Setup processes.
Able to perform duties of Tech I - Tech III and other duties as assigned.