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We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

Position Summary

The External Auditor, Supplier Quality and Quality Systems, is responsible for supporting the LOTTE BIOLOGICS supplier qualification and external auditing program; to include external audit schedule maintenance, third-party outsourced external audit program, external audit execution, and audit follow-up activities. This includes management of supplier change notification (SCN) program, and supplier qualification program for commercial and clinical material suppliers, third-party contract testing laboratories, IT Application developers and system integrators, and other service providers, as applicable.

Duties & Responsibilities

+ Manage the Supplier Change Notification (SCN) program. Responsibilities include, but are not limited to, triage meeting facilitation, creation, ownership and quality approval of supplier change notifications (SCNs), documenting potential impact to supplier qualification requirements and Approved Supplier List (ASL).

+ Support of the external audit program through schedule maintenance, external audit execution, and auditing follow-up activities, to include tracking, monitoring and closure of associated audit findings, and supplier CAPA.

+ Support of the third-party external audit program through coordination of third-party external audits, purchasing of third-party external audits (e.g. RX-360), monitoring and closure of associated audit findings, and supplier CAPA.

+ Support of the service provider qualification program ensuring qualification activities are met, QA approved, and audits conducted at defined frequencies.

+ Support site and network projects regarding supplier qualification and external audit program, including quality management system implementation, and continuous improvement activities.

+ Participate in and/or provide support (front room or back room) during client audits and regulatory inspections.

+ Provide QA support for Audits, Findings, CAPA, Effectiveness Check records as record owner.

+ Review site SOPs and other documents requiring QA review and approval.

+ Provide QA compliance oversight for site activities. Ensure that written procedures are followed and exercise sound judgment in evaluation of quality systems, processes, and procedures for compliance.

+ Provide developmental feedback and coaching; create a collaborative environment to enhance unit performance and integration across site departments.

Education & Experience

+ Bachelor’s degree and at least 5 years relevant experience in the bio-pharmaceutical industry, with a minimum of 3 years’ experience in Quality Assurance or related technical function and increasing cross-functional responsibility.

+ An extensive knowledge and understanding of FDA, EU, ICH, ISO, PIC/S and other health authority guidelines.

+ American Society for Quality (ASQ) Certified Quality Auditor or equivalent preferred, willingness to become certified.

+ Must have project management skills with the ability to lead cross-functional problem-solving teams.

Knowledge, Skills, Abilities

+ Familiar with and able to interpret relevant regulations, and regulatory agency inspection expectations.

+ Demonstrate flexibility and capability of managing multiple tasks.

+ Ability to shape the culture by demonstrating examples of compliance behaviors and attitudes.

+ Demonstrate excellent organizational and time management skills required to effectively prioritize work.

+ Detail-oriented with a sense of urgency for completing tasks.

+ Experience with implementing and execution of compliance-related programs.

+ Ability to perform tasks completely and independently and complete assignments without detailed direction.

+ Communicate complex information clearly and concisely.

+ Demonstrate knowledge of subject matter related to quality and compliance.

+ Display the flexibility, confidence, and decisiveness to effectively establish proper priorities and manage through the dynamic of frequent change.

+ Demonstrate problem solving ability, interpersonal, oral and written communication skills.

+ Ability to prioritize objectives from multiple projects, adhere to scheduled timelines, while maintaining flexibility and attention to detail.

+ Superior interpersonal skills to facilitate the development of effective partnering relationships with a diverse array of individuals including counterparts in partner groups, peers, and team members.

+ Demonstrate knowledge of a variety of computer software applications in word processing, spreadsheets, and database software

Physical Demands

Primarily an office-based position requiring sitting for prolonged periods, walking, repetitive use of arms, hands, and wrists.

Work Environment

Primarily office space. Occasional exposure to both manufacturing and laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents.

Travel

This position may require up to 25 % travel.

Target Bonus

10%

Work Location

East Syracuse, NY

New York Pay Range

$76,000 — $113,000 USD

We are an Equal Employment Opportunity (“EEO”) Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!