Aseptic Area Team Leader, MD Fill, 2nd Shift
__jobinformationwidget.freetext.LocationText__
Waco, TX
- Operations
- Full-time
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Purpose
Responsible for the daily supervision and training of operating personnel in the production of clinical or commercial products. Responsible for the accurate and timely completion of production related cGMP documentation. Ensures the effective use of material, equipment, and personnel in producing quality products.
Responsibilities
- Leads the team inside the Multi Dose Filling clean rooms throughout the assigned shift.
- Serves as an aseptic mentor, including, but not limited to the following:
- Train personnel in Aseptic Techniques and processes.
- Complete daily inspections of the physical conditions of the aseptic area.
- Communicate openly to operators and supervisors in aseptic core principles to provide mentoring regarding observed performance.
- Oversees all tasks on the floor as they are carried out and provides assistance and troubleshooting where needed.
- Communicates end of shift status to the next shift supervisor and to the unit manager as required for smooth hand off on a daily basis. Uses the shift log approach to manage the days goals and responsibilities in line with the priorities.
- Reviews, on a shift wide-basis, the batch records for error and deviations, signing off responsibility to the next supervisor after this review.
- Provides daily guidance primarily to nonexempt employees. Coordinates activities of sub-group and actively works with other sub-groups. Evaluates staff performance.
- Partner with Quality to ensure compliance when issues arise.
- Assist in cleaning, setup, and operation of the Filling equipment per critical business needs.
- Bachelor’s degree plus 2-5 years relevant operations experience or 5-10 years of relevant operations experience.
- Familiarity with documentation in a highly regulated environment; good writing skills.
- Ability to operate specialized manufacturing equipment and computers as appropriate.
- Ability to interpret and apply cGMPs.
- Working knowledge of safety, quality systems, and cGMPs is required.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is a considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html