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Senior Quality Associate II

Company Description

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 XFacebookInstagramYouTubeLinkedIn and Tik Tok.

Job Description

Purpose

The Sr Quality Associate II provides leadership and direction to the Quality Function that they are responsible for within Operations. This role is responsible for the effective implementation of the Quality functions within operations for which they would be responsible for. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Training, Non-conformance Investigations, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr Quality Associate II would be expected to work within a budget and leads a team who are responsible for compliance and quality systems implementation. Expectations that the Sr. Quality Associate II will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

Responsibilities

  • Leads and influences peers and colleagues within the scope of their work.
  • Responsible for various aspects of quality assurance related to products produced at the plant.
  • Responsible for the effective organization, administration, and training within their functional area.
  • Independently troubleshoot and resolve quality compliance issues.
  • Provides technical guidance on Non-conformance issues to departments.
  • Communicates with Management for Quality Management Review, Quality Initiatives, etc.
  • Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.

Qualifications

  • Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
  • 8+ years of combined experience preferred (5 years minimum experience with 3 years working in a relevant area such as Quality Assurance or Control, Validation, or Quality Laboratories). 
  • Must be familiar with use of electronic document management and laboratory information management.
  • Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements.
  • Strong communication Skills, both oral and written

 

Additional Information

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 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

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Average salary estimate

$90000 / YEARLY (est.)
min
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$80000K
$100000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Senior Quality Associate II, AbbVie

If you have a passion for maintaining top-notch quality standards, then the Senior Quality Associate II position at AbbVie in Waco, TX might be your next great opportunity! In this dynamic role, you will lead and provide direction to the Quality Function within Operations, ensuring that everything runs smoothly while adhering to our high-quality standards. This includes overseeing various aspects of quality assurance related to drugs and packaging materials, and you will have the chance to engage with a range of exciting responsibilities—from troubleshooting compliance issues to communicating vital quality initiatives with management. Your expertise in quality systems will play a pivotal role in ensuring that our manufacturing teams achieve their goals efficiently, maintaining the integrity of our processes. Collaborating with diverse teams, you’ll also lead training efforts within your functional area, guiding colleagues on best practices in quality assurance and validation. At AbbVie, you won't just be applying your knowledge; you'll also be a key player in shaping the future of quality in our industry. So if you're eager to work in an environment that values innovation and integrity, where you can make a significant impact in healthcare, we invite you to consider this exciting opportunity!

Frequently Asked Questions (FAQs) for Senior Quality Associate II Role at AbbVie
What are the key responsibilities of a Senior Quality Associate II at AbbVie?

As a Senior Quality Associate II at AbbVie, your key responsibilities will include leading the quality assurance functions for drug and packaging materials, ensuring compliance with AbbVie Quality Systems and cGMP regulations, and providing technical guidance in non-conformance issues. You’ll also be working closely with management to communicate quality initiatives and oversee training efforts within your team.

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What qualifications are needed for the Senior Quality Associate II role at AbbVie?

To qualify for the Senior Quality Associate II position at AbbVie, you will need a Bachelor’s Degree in a related field such as Physical or Life Sciences, Pharmacy, or Engineering. Additionally, a minimum of 5 years in quality assurance or relevant experience is essential, with at least 3 years specifically focused on Quality Assurance or Control, Validation, or Quality Laboratories.

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How important are communication skills for a Senior Quality Associate II at AbbVie?

Communication skills are extremely important for the Senior Quality Associate II at AbbVie, as you will be responsible for communicating quality management reviews and initiatives to various stakeholders, including management and your team. Strong oral and written communication skills will help you effectively convey complex quality information and improve team collaboration.

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What kind of training will the Senior Quality Associate II provide at AbbVie?

In the Senior Quality Associate II role at AbbVie, you will provide training on best practices in quality assurance, regulatory compliance, and operational standards. This includes educating team members on relevant quality systems and ensuring that everyone is aligned with the mission to maintain high-quality levels across all operations.

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What type of environment can a Senior Quality Associate II expect at AbbVie?

At AbbVie, a Senior Quality Associate II can expect a collaborative and innovative environment, where quality and compliance are prioritized. The team is dedicated to making a significant impact in the healthcare industry, fostering a culture of integrity, diversity, and inclusion while encouraging continuous learning and professional development.

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Common Interview Questions for Senior Quality Associate II
Can you describe your experience with quality assurance processes?

When answering this question, provide specific examples of your previous work in quality assurance, including the methodologies and standards you followed, your role in applying these processes, and how your efforts contributed to improved quality outcomes in your previous roles.

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How do you handle non-conformance issues?

In your response, emphasize your problem-solving skills and detail the steps you take to investigate a non-conformance issue, including identification, assessment, corrective actions, and follow-up procedures that lead to preventing similar incidents in the future.

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What is your knowledge of cGMP regulations?

Demonstrate your understanding of current Good Manufacturing Practices (cGMP) by discussing how you have applied these regulations in your previous roles, what specific compliance issues you've encountered, and how you ensured adherence to these standards in practice.

Join Rise to see the full answer
How would you manage quality assurance training for new employees?

Share your approach to designing and implementing training programs, highlighting the importance of tailoring training to enhance understanding of quality systems and emphasizing the practical applications employees will encounter in their roles.

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Can you provide an example of a successful quality initiative you've led?

When addressing this, narrate a specific quality initiative you were involved in, detailing your approach, the team’s collaboration, measurable outcomes, and how it led to improved compliance and quality standards.

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How do you prioritize multiple quality assurance tasks?

Discuss your time management strategies, focusing on how you use prioritization techniques, tools, or methodologies to ensure that critical tasks are addressed effectively without compromising quality standards.

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What strategies do you use to ensure compliance with quality systems?

Explain your proactive approaches to maintaining quality compliance, including regular audits, continuous monitoring, and fostering a culture of accountability and awareness among team members.

Join Rise to see the full answer
How do you communicate quality issues to non-technical stakeholders?

When responding, emphasize your communication skills and how you adapt your messaging to ensure clarity and understanding for non-technical audiences, helping them grasp the significance of quality issues in a relatable manner.

Join Rise to see the full answer
What has been your experience with electronic document management systems?

Detail your familiarity with electronic document management systems, specifying the systems you have utilized, and how they have improved quality assurance processes through better organization, accessibility, and compliance tracking.

Join Rise to see the full answer
Why are you interested in the Senior Quality Associate II position at AbbVie?

In this answer, express your enthusiasm for AbbVie’s mission and values, highlighting specific reasons such as the company's commitment to innovation and quality in healthcare and how your skills align with the role's requirements.

Join Rise to see the full answer
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AbbVie’s mission is to discover and deliver innovative medicines 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: i...

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March 18, 2025

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