CAPA Specialist - Processing (2nd Shift) $3k Sign-on Bonus

Company: Abbott Laboratories
Location: Mishawaka
Posted on: August 3, 2022

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Nourish the world and your career as part of the Nutrition team at Abbott.Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac -, PediaSure -, Pedialyte -, Ensure -, Glucerna - and ZonePerfect - - to help get the nutrients they need to live their healthiest life.WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:

• Fast paced work environment where your safety is our priority
• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Vacation - 3 weeks accrued vacation (1st year is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Company Paid Pension Plan
• 401(k) retirement savings with a generous company match of 5%
• The stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: WHAT YOU'LL DO Progresses investigations through the CAPA system in support of non-CAPA organizations. Works closely with other functional areas with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems. Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers, and that required standards and/or procedural requirements are met. Is an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct. MAIN RESPONSIBILITIES Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from the division's Quality System. Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance. Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area. Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner. Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements. Supports the attainment of division goals and objectives. Accountable to the Quality Organization for achieving mutually agreed upon objectives. Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances. The CAPA System is a key inspection focus of worldwide regulators and auditors. The system must be usable, simple, sustainable and well maintained. Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls. Decisions and recommendations made by this position impact quality decisions for marketed products and the division's Quality System. QUALIFICATIONS Education Education Level minimumAssociates Degree ( - 13 years)orBachelors Degree ( - 16 years)Preferred Experience/Background Minimum 2 yearsMinimum of two (2) years of experience working in a regulated environment or experience performing investigations. Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 is preferred.Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.Good project management skills to deliver an effective service in a timely manner.Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.Able to work independently..

Keywords: Abbott Laboratories, Mishawaka , CAPA Specialist - Processing (2nd Shift) $3k Sign-on Bonus, Other , Mishawaka, Indiana