Quality Specialist, Document Control

Requisition ID: 67335

Date: Sep 26, 2024

Location:

Scottsdale, Arizona, US

Department: Quality

Description:

Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

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.

#LI-KR1

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.