Senior Quality Assurance Supervisor
3 days ago
Job Overview
">We are seeking a highly skilled and experienced Senior Quality Assurance Supervisor to join our team at AbbVie. As a key member of our quality assurance department, you will be responsible for ensuring that our tissue services process meets the highest standards of quality and compliance.
">About Us
">AbbVie is a global biopharmaceutical company committed to discovering and delivering innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. Our mission is 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.
">Compensation and Benefits
">We offer a comprehensive package of benefits, including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) eligibility to employees. This role is eligible to participate in our short-term incentive programs. Estimated salary range: $80,000 - $110,000 per year.
">Key Responsibilities
">- ">
- Supervise the activities associated with the donor release process and ensure it conforms with Standard Operating Procedures (SOPs) and all applicable state and federal standards and FDA and AATB regulations.">
- Communicate with management on a routine basis and escalate issues as needed. Supervise the team by example, build relationships, and collaborate with internal and external customers.">
- Responsible for managing the activities required to meet the monthly release target.">
- Responsible for training, developing, motivating, and coaching of the team.">
- Responsible for ensuring adequate resources/staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance to organizational policies.">
- Responsible for communicating and/or facilitating personnel actions; including but not limited to hiring, termination, salary and performance reviews, disciplinary action, approving paid time off, and approving overtime.">
- Provide supervision, coaching, and guidance, monitoring of activities, required problem resolutions, and projects. Create and sustain a positive team environment.">
- Initiate, investigate, review, and/or partner in the identification of discrepancies and issue resolution for Nonconformances, CAPAs, and other quality records as applicable. Initiate IT tickets and Facilities tickets, and Equipment Work Requests (EWRs). Assist with corrective actions in cross-functional teams to mitigate recurrence of similar issues.">
- Initiate, assess, coordinate implementation plans, and/or drive ECOs for process related to donor release. Provide input and support for other change controls related to the Tissue Services process.">
- Track and monitor Key Process Indicators (KPIs), implements initiatives to increase departmental and cross-functional awareness and process improvements.">
- Perform donor review, releases, and any other activities as needed.">
- Ensure Tissue Services documentation is accurate and compliant.">
- Perform applicable ERP training, transactions, transfer, status changes, and other activities as needed.">
- Responsible for the initiation and follow-through of the change control processes.">
- Active member in other cross-functional collaborative efforts and attends huddles, team meetings, and project meetings.">
- Supports 5S methodology and ensures the area is safe and effective working environment.">
Requirements
">- ">
- Bachelor's degree or equivalent preferred.">
- 3-5 years' experience in a GMP environment performing related duties as listed in Key Duties & Responsibilities.">
- Ability to work a varied schedule with some potential weekend, early morning, or late evening hours, if needed.">
- AATB Certification preferred.">
- SAP Knowledge.">
- Advanced computer skills – high knowledge and understanding of Windows-based computer systems such as Microsoft Office Suite.">
- Experience with Current Good Manufacturing Practices (cGMPs) and working in a regulated industry; familiarity with AATB, FDA, and/or USP regulations guidelines.">
- Experience with Enterprise Resource Planning (ERP) software, such as Oracle or SAP.">
- Strong understanding of quality systems.">
- Basic knowledge of statistical techniques and quality tools.">
- Detail-oriented and self-motivated.">
- Ability to carry out detailed written or oral instructions.">
- Ability to work and communicate (soft skills) with others in a professional and effective manner to build strong, lasting customer relationships and developing a strong team by support and leadership of group work area.">
- Ability to handle a wide variety of tasks under critical time constraints.">
- Strong organizational abilities and problem-solving skills.">
How to Apply
">If you are a motivated and results-driven individual looking for a challenging opportunity to grow your career, please submit your application, including your resume and cover letter.
">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.
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