Quality Control Inspector IV

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.

Responsible for, but not limited to, inspecting, and receiving human and porcine tissue, batch record review, cleaning, cycle count, product/tissue quarantine, media change and disposition activities. Ensures quarantine, receiving, cycle count, cleaning, media change and review activities are performed in accordance with all applicable procedures, regulations, and established specification requirements.

This position is required to support overall departmental needs such as data trending, audit SME support, documentation updates among other tasks. Provide technical support to teams and cross-functional teams to ensure effective operations. Proficient in all areas of QC Tissue Receipt. This role is also responsible for identifying, coordinating, and implementing 5S and Lean Six Sigma continuous improvements initiatives. 

Supports and partners with cross-functional teams to resolve any issues or nonconformance encountered.   Assists in documentation updates and related change controls activities as needed.   Perform applicable actions for Exception Reports (ERs), CAPAs, Supplier Related ERs, LIR’s, Change Controls (ECOs), etc.  

• Performs receiving and reviewing activities in accordance with applicable procedures.


• Communicates with management and escalates as needed, leads the team by example, build relationships and collaborates cross-functionally.


• Responsible for training, developing, motivating, and counseling of the team strengthening the core and developing new skills. 


• Quarantine product as deemed necessary for identified non-conforming product. Complete transactions as deemed necessary for accept able or rejected non-conforming product.


• Investigate/Initiate Non-conformance’s and CAPA’s.


• Initiate change controls for identified gap assessments and process improvements. 


• Provide review and monitoring of area processes and documentation for tasks for completeness and accuracy.   In partnership with the area manager, ensures compliance and adherence to procedures.   Partner with cross-cross functional departments for ensuring accurate documentation for work and resolution of issues.


• Responsible for tracking and follow-up of issues and updating metrics.


• Active member in other cross-functional collaborative efforts and attends quality tuddles, team meetings, and project meetings. 


• Assist Supervisor with various projects and metrics assisting with the establishment of KPIs.


• Maintains 5S and ensure area has supplies needed for the functionality of the team.


• Complete all necessary training on time.


• Perform  Cleaning and Cycle Counting as deemed necessary per procedures.


• Perform media change as deemed necessary per procedures.



 
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The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.  

·        Ability to carry and lift boxes weighing up to 50 lbs.   

·        Ability to work varied schedule with some potential weekend, early morning or late evening hours, if needed.

·        Ability to work with human and porcine raw materials and finished goods specicially defined functional areas.

·        Must be comfortable working in a lab, warehouse and manufacturing settings.

·        Willing to work with potentially biohazardess materials, including cadaveric tissue.

·        Ability to walk, lift, bend, squat, stoop, stretch, sit and stand for long periods of time.

·        Ability to carryout detailed written or oral instructions.

·        Ability to handle a wide variety of tasks under critical time constraints.

Education and Experience

·        Bachelor’s degree preferred   or 5+ years of experience in a cGMPs, GDP, ISO, FDA regulated industry preferred

·        AATB certification preferred.

·        Experience in leading manufacturing and production teams in some capacity, such as shift or team lead or any previous supervisory experience preffered.

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 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 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.