Quality Assurance Analyst

Avantor•Carpinteria, CA

2d•$69,000 - $110,975•Onsite

About The Position

At Avantor, people are the most important part of our success because they drive our global performance. That’s why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantor’s Quality Assurance & Quality Systems vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits. The Quality Assurance (QA) Analyst is responsible for contributing to the performance of our Quality Management System (QMS), ensuring compliance to ISO standards/corporate policies and creating a culture of quality across the business. The QA Analyst is responsible for support functions related to the quality systems team, clerical and administrative support, data entry and other supporting functions to ensure maintenance of policies and procedures according to applicable regulatory requirements. The individual will be required to interpret customer purchase orders for quality obligations and will need to negotiate terms of those requirements. This position may also support or participate in the preparation and implementation of QA policies and procedures, perform and manage internal audits, assist or lead customer audits and regulatory inspections, resolve process flow issues, and ensure standards and safety regulations are observed. The QA Analyst must have excellent communication skills to document and perform QA activities, such as writing clarification letters, creating internal audit reports, managing root cause investigations of audit findings, preparing Corrective and Preventive Action reports (CAPA), communicating directly with customers, creating and administering internal training materials and collaborating among cross functional departments. The QA Analyst is an integral member of the site-based leadership team and will actively represent Quality at different facilities. The focus of the position is to develop, perform, manage and continuously improve quality assurance related activities in compliance with ISO and other related standards/guidance. This position reports into the Sr. Supervisor, Quality Systems and will be onsite at our Carpinteria, CA location.

Requirements

High School diploma required. Bachelor’s degree in science (Biology, Chemistry, Environmental, etc.) preferred or demonstrable evidence of job-related professional experience and/or strong internal knowledge of Avantor.
1-3 years of quality and/or contract management
Excellent communication skills (verbal and written); ability to effectively communicate with customers, registrars and Avantor associates of different levels.
Strong organizational and time management skills, ability to prioritize work.
Ability to document processes and lead consensus for standardization across Avantor network.
Proficient computer/Microsoft Office skills.

Nice To Haves

Experienced or certified internal auditor for ISO9001 and AS 9100 or related standards/guidance/regulations (ex. GxP, IPEC, etc.) preferred.
Project management experience preferred.
Experience in using quality management/problem solving principles, tools and methodologies (ex. Lean principals, Six Sigma, PDCA, Kaizen, etc.) preferred.
Knowledge of SAP preferred.
Experience with Agile or similar QMS software preferred.
Strong knowledge of distribution, manufacturing, or production operations.

Responsibilities

Ensure purchase order contractual obligations are met for quality related aspects through review, interpretation, and negotiation.
Root cause investigations related to customers’ complaints against quality process failures/nonconformances, issue CAPAs and ensure they are closed on time, create and issue formal customer responses, and verify CAPAs are properly implemented and effective.
Prepare, participate and host Quality Assurance (QA) related activities (e.g., internal audits, continuous improvement activities, internal training, external audits from customers, registrars, regulatory agencies (e.g., FDA, DEA, etc.) and site tours.
Create, review, and update controlled documents (Standard Operating Procedures (SOPs), Work Instructions, Forms, Training Materials).
Identify and implement corrections or process improvements that will ensure the health and compliance of our QMS. Including participating in ABS events related to reduction of errors, process improvements, and improved customer experience.
Support Lead Auditors with various problem-solving principles, tools and methodologies (e.g., Lean principals, Six Sigma, PDCA, Kaizen, etc.).
Collect, manage and maintain quality data/records, prepare routine/special reports and interpret such information to assess the health of our QMS and make recommendation to management.
Participate in the ongoing surveillance and recertification activities required to remain ISO Certified.
This position is customer facing and often supports our commercial team. It includes, but is not limited to, preparing for and participating in routine customer calls/events (e.g., Quarterly Business Reviews, Quality Summits, Gemba Walks, etc.)
Attend and participates in departmental and/or corporate events (e.g., Town Halls, Management Review Meetings, etc.) and may serves as the Subject Matter Expert for Quality to support various continuous improvement initiatives, projects, Kaizens, etc.