Quality Control Supervisor

«out AbbVie 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Want to join an award winning team? We OFFER that. Ready to make a Worldwide impact? We OFFER that too. Welcome to AbbVie! At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond. We are now recruiting a Quality Control Supervisor to join our diverse Quality team in Clonshaugh. The QC Supervisor is recognized as a member of the Clonshaugh site management team. The QC Supervisor is responsible for monitoring and directing the day-to-day activities in the QC laboratory, including adherence to the System for Management. This includes ensuring that the QC laboratory supports the QA, Technical Service and production teams according to schedule and plan to ensure targets are met and that laboratory personnel are properly trained and qualified. The QC Supervisor is required to adhere to and enforce all applicable laws and regulations as well as internal Company policies and procedures in the performance of the job role. This position supervises a team of QC Chemists and reports to the Senior Manager, QC. This position may act as a deputy for the Senior Manager, QC. as deemed necessary. .*So let’s tell you a little more about this role… Key Responsibilities: Supervise daily laboratory operations, ensuring laboratory personnel execute their responsibilities in strict accordance with relevant regulatory guidelines. Support the weekly and daily production schedules and participate in the daily Tier 1 meetings to review shift production goals and to review execution against the shift’s goals. Attend with the supervisors of support functions daily Tier 2 meetings to review shift production goals and execution against the shift’s goals. Escalate production floor issues related to laboratory personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Tier 3 according to manufacturing and site escalation process. Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations. This includes building staff capability by providing ongoing coaching and mentoring of direct reports, providing timely recognition as well as performance counseling, building and executing development plans, and providing career counseling for career progression. Maintain expected standards by reporting weekly on leader standard work activity through standard tracking mechanism. Provide direction to laboratory personnel internally and at contract laboratories to ensure production is able to complete the targets specified in the daily production plan. Manage samples for analytical testing and the generation of results at external /contract laboratories Ensure proper coverage in the laboratory by trained, skilled chemists. Ensure that laboratory personnel properly follow procedures and submit required documentation completely, accurately and timely according to current cGMPs. Ensure data reports on own team’s performance are current, accurate, and distributed according to defined procedures. Maintain metrics for laboratory calibration, maintenance and utilization of instrumentation and equipment. Contribute to the continual improvement of all laboratory documentation to ensure they are current, accurate, and clearly define process and role responsibilities. Schedule and/or deliver training to laboratory personnel to ensure staff has the requisite skills to perform their work correctly, safely, and compliantly. Enforce cGMP, safety, housekeeping, and security procedures in the laboratory, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership. Provide hands on training, support, and coaching to laboratory personnel and make timely decisions to ensure that performance Service Level Agreements (SLAs) can be met. Maintain accountability for own team’s performance metrics that support the annual operating plan and site strategic plan objectives. Seek process innovation and continuous process improvement in laboratory area. Develop, execute, and evaluate scientific studies to improve the performance of current analytical methods. Lead the development and qualification of methods and sampling techniques for use in cleaning validation studies to support the site product mix. Assess new laboratory equipment purchases for laboratory effectiveness, efficiency and compliance. Provide guidance and training to QC Staff members on various GMP related activities. Provide timely status reports to laboratory management on the status and effectiveness of the laboratory Installation, Qualification, calibration and maintenance programs. Complete and conform to all training requirements for job role, including company-required and job role-specific training. Carry out one to one meetings with at least one direct report weekly. Prepare and conduct performance appraisals in accordance with Company guidelines. May lead department initiatives and projects Qualifications Education: Bachelor’s Degree or above in Chemistry or related Science Technical Skills and Experience: Minimum of 3-5 years relevant Quality Control experience. Good understanding of pharmaceutical manufacturing operations Minimum two years direct supervisory experience or demonstration of staff mentoring. Experienced in aligning individuals and teams to business objectives Exposure to Lean manufacturing concepts Experience in managing by metrics Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory. Demonstrate competency in the operation, calibration and qualification of common analytical instrumentation e.g. HPLC, Dissolution, GC, FTIR, UV/Vis and other instrumental and Wet chemistry technologies used in pharmaceutical Quality Control Laboratory. Demonstrate strong analytical laboratory skills in a variety of applications and the ability to troubleshoot for investigative purposes. Experience in method validation/method transfer and compendial verifications. Scientific writing i.e., protocols, reports and investigations. So, does this all sound like the right role for you? Then come join Abbvie! AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.