Title:  QA Specialist

Onsite position in  Puerto Rico

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

In this role, you will be responsible for compliance to Issue Review (IR), Complaint Handling, and Corrective and Preventative Action (CAPA) processes and requirements by serving as a subject matter expert and providing guidance to IR, Complaint, CAPA owners and working closely with all areas in the development of IR, Complaint, CAPA activities and the rigorous assessment of CAPA documentation.  Supports Quality in various functions assigned.

Essential Duties and Responsibilities:

• Provide continuous and extensive assessment of all IR, Complaints, CAPA activities and documentation to ensure compliance with business practices, regulations, and ISO standards.
• Support the implementation of standardized procedures and systems for IRs, Complaints, and CAPA.
• Provide training for users in IRs, Complaints, and CAPAs to include investigation, root cause analysis, and review.
• Assist users with the development and documentation of problem statements, containment, implementation, correction, root cause, action plan, risk management and effective monitoring.
• Deliver metrics for IRs, Complaints, and CAPA to include weekly management tracking reports.
• Implement measures to monitor the effectiveness of the systems.
• Conduct review and approval of the IRs, Complaints, and CAPAs with attention to detail, review for completeness, accuracy, effectivity, and timeliness to include extension requests.
• Liaise with functional groups, facilitate and mentor teams through all stages of the processes.
• Ensuring users provide consistency to the IRs, Complaints, and CAPA system content.  Follow IRs, Complaints, and CAPAs throughout the lifecycle of the content.
• As Subject Matter Expert, facilitate and coach IRs, Complaints, and CAPA teams in the application of problem-solving techniques and promote its use and development.
• Supports internal and external audits, inspections, batch history record review, calibrations, and record / document control.

• Performs other duties as assigned by the Quality Supervisor or Manager.
• Other duties as assigned.

Basic Qualifications: 

• BS/BA degree preferably in a technical discipline (Business, Operations, Engineering, or Science).
• 0-3 years of experience
• List any required certifications.
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.  Strong analytical and decision-making skills.
• Experience in technical documentation, quality tools, and process improvement techniques.
• Influence management skills; ability to work constructively across all functions (internal and external customers).
• Excellent communications (including both written & oral methods), interpersonal, problem solving (including root cause failure analysis methods), planning/organizational, and negotiating.
• Computer skills required mainly with MS Office Applications, MasterControl, and other statistical analysis systems.
• Understanding of manufacturing and plant operations. 

Preferred Knowledge, Skills and Abilities:

• Experience with GMPs, ISO 13485, and ISO 9000 standards.
• ASQ certification highly desired.
• Black Belt certification a plus.
• Chemistry or Engineering degree preferred.
• Graduate degree (MS) a plus.

Travel Requirements:

• Minimal.

Physical and Mental Requirements:

• Perform job duties as required with limited physical demands and some travel may be required.

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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.