2nd Shift Senior MQA Supervisor - AbbVie

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose

Provides supervision and direction to Quality Assurance staff members within the manufacturing operations. Maintains GMP compliance, manufacturing quality, system execution and quality planning for supported manufacturing areas.

Responsibilities

• Supervise a team of technicians in the Quality function to include selection and hiring, setting performance expectations, performance assessment, train and staff development and resolution of personnel issues
• Provide Quality support on the manufacturing shop floor
• Responsible for supporting Operations efforts in meeting established production schedule
• Partner with Operations employees to document exception documents, including re-inspection and resolve other outstanding plant quality/compliance issues
• Propose changes update, author, and implement departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance
• Provide leadership and act as primary resource at site
• Investigate QC hold, quarantine and reject for materials not meeting standards, ensure the initiation of exception documentation and oversee the implementation of any corrective action
• Responsible for the review and approval of Procedures and Change Requests
• Assist/serve/provide feedback on continuous improvement initiatives/teams
• Reviews and releases batch records

• Bachelor Degree, BA/BS in Science, Business or related field or equivalent related experience required.
• 2-3 year experience in QA, Manufacturing or Business teams
• Knowledge of regulations and standards affecting pharmaceutical products
• Ability to partner with QA & Operations personnel in order to influence/make effective QA decisions that are consistent with regulatory requirements and support overall production demands
• Ability to make effective QA decisions independently in a fast-paced production environment
• Ability to independently manage QA team including hiring, coaching, counseling, and developing personnel with minimal support from QA management
• Strong interpersonal and communication skills. Ability to effectively resolve conflict and lead efforts to resolve critical situations
• Good writing skills to create, edit and review cGMP documents, operating procedures and manufacturing documents

Key Stakeholders 

Please assign to Job Code F6205

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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. ​

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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 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