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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
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RESUMEN GENERAL (SUMMARY):
The person in this role supports the overall implementation of effective foundational Quality Systems for medical devices and pharmaceutical operations. Specifically, this role’s main responsibility is to formally implement the Solutions Stability Program oversight by Aibonito Quality, provide Quality Assurance (QA) oversight to the Quality Control Laboratories (approximately 70% jointly) and to drive the Internal Audit Program, by either directly conducting or coordinating with other Puerto Rico site resources to conduct audits in the Aibonito site (approximately 10%). The person in this role will need to drive Root Cause Analysis sessions in support of selected nonconformances from the Quality Control Laboratories or others from across the site (approximately 10-20%).
A key objective of this role is to ensure cGMP is consistently followed for mentioned processes and to be inspection ready at all times by ensuring quality and compliance are consistently build into day to day operations. The role is as an individual contributor, coaching others to help drive for right first time execution in daily operations, being able to influence across boundaries and levels, confronting and challenging with courage while working in collaboration with others. The role requires acquiring and analyzing data, taking or supporting decision making based on data, information, providing inputs from a Quality Control Subject Matter expertise standpoint, cGMP expectations, Baxter’s Quality System, while applying Risk Management principles. The person in this role must ensure escalation of significant quality issues to the Quality Systems Manager, Quality Control Manager, Quality Management Representative (QMR) and Plant Manager, as applicable within a timely fashion (e.g., in case of Stability Out of Specifications (OOS)).
The person in this role will also need to seek learning and getting cross trained in other Quality Systems, since he/she may occasionally need to support the site Documentation Management process, the nonconformance (NCR) handling process, the Corrective and Preventive Actions (CA/PA) process, the Complaints handling process, the Quality Management Review process or the Calibrations program (within the Quality Systems group scope), for example in case of vacations, workload peaks or unexpected circumstances (approximately 0-10%).
TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSIBILITIES):
Responsible for conducting the Solutions Stability Program oversight from a site perspective since tests are conducted off-site; investigations for Out of Specifications (OOS) and atypical events are initiated off-site and consulted with the site for feedback. Liaise with off-site Stability personnel, ensuring applicable Stability procedures are followed consistently, including testing within allowed time periods, trends analysis, such that the site is inspection ready on aspects related to this program. Ensure the Solutions Stability Program, the Quality Control Laboratories and the Internal Audit program remain in control in terms of compliance to procedures, and that significant issues are escalated upon review of trends or atypical events. Drive identification and implementation of key actions to assure this objective is consistent met. Review and approve LIEEs (Phase I Laboratory Investigations) for the Quality Control Laboratories from the QA standpoint and ensuring the interface with the site nonconformance system is consistently followed. Review and approve SOPs and other GMP documents for the Quality Control Laboratories from the QA standpoint to ensure cGMP expectations are captured while operational activities in the laboratories are facilitated, helping drive users to right first time execution. Oversee QC Laboratories KPIs and help QC personnel identify actions to improve, as applicable. Ensure prompt notification and escalation of potentially significant quality issues to Quality Systems Manager and QMR. Coordinate, drive Root Cause Analysis sessions, identification of CAPAs, and write Investigation Reports in support of selected nonconformances from across the site. Ensure those investigations are commensurate to the nature (e.g., severity, defect type, occurrence) of the reported issues, considering appropriate scope, breadth and depth. Liaise with internal auditors in PR sites and SMEs to perform site internal audits. Conduct data analysis and identify actions applying risk management principles and problem solving tools, as needed. Generate Quality KPIs and preparation of Management Review materials related to key function and support others in this process, as needed. Ensure pillars of Simplification-Speed-Collaboration-Courage are demonstrated through results. Assist the Quality Systems Manager during FDA inspections, MDSAP or corporate audits. Drive and ensure communication and learning of quality issues and topics throughout different levels, roles and communication forums, especially within the QC Laboratories. Support implementation of Six Sigma/ Lean/OPEX initiatives in the areas of responsibility. Ensure effective communication and partnership with areas of interface with a key focus on the Chemistry & Microbiology Laboratories, Manufacturing, Facilities and QA. Help drive the site 2018-2020 Quality Plan in key areas of main responsibility (Stability Program, QC Oversight, Internal Audit) working in partnership with all site functions. Support control of Quality department budget. Assist Quality Systems Manager, Quality Control Manager and QMR in the preparation and administration of department's budget. Promote a zero-harm work place, and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
DEMANDA FISICA (PHYSICAL DEMANDS):
Light Work: Exerting up to 20 pounds of force occasionally and/or a 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Physical demands requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible.
EDUCACIÓN Y/O EXPERIENCIA (EDUCATION AND/OR EXPERIENCE):
Bachelor Degree in Science, preferably Chemistry or Microbiology. Five to eight years of experience in Pharmaceutical Industry (preferred) and/or Medical Devices Industry. Licensed Chemist preferred.
CALIFICACIONES (QUALIFICATIONS):
- Knowledge of 21CFR Part 210 and 211 as well as 21 CFR Part 820.
- Ability to work with multi-functional teams.
- Strong written and communication skills.
- Willing to learn.
- Analytical Thinking & Problem Solving skills.
- Flexible to changes; adaptable.
- Preferred: Experience applying Risk Management principles.
- Preferred: Basic knowledge of Project Management principles.
- Preferred: Basic knowledge of Statistical Process Control and basic statistics.
- Computer skills and knowledge of MS Office (Word, Excel, Power Point, etc.
- Willing to travel occasionally within Jayuya, Guayama and Aibonito sites as well as abroad.
IDIOMA (LANGUAGE):
English and Spanish
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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