Senior Quality Specialist, Quality Assurance at LOTTE BIOLOGICS

Overview:

We are LOTTE BIOLOGICS! 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.

We deliver therapies that make a Healthier World!

To help us meet our mission LOTTE BIOLOGICS is in need of a Sr Quality Specialist, Quality Assurance responsible for the approval of investigations related to the Quality Control laboratory, Environmental Monitoring excursions, quality system/compliance deviations, and the biologics manufacturing process. The position reviews and approves revisions to MBRs, SOPs, laboratory documentation, and ensures the quality of manufactured products adhere to the highest standards of GMP compliance.

Duties/Responsibilities:

• Drives performance within the quality assurance operations team and ensures key quality metrics are met.
• Provides functional area support in identification, reporting and resolution of deviations or non-conformances.
• Demonstrates independent decision making and leadership on behalf of the quality organization.
• Ensures all quality review and support activities adhere to the highest standards of GMP, EHS and regulatory compliance.
• Approver on all impact levels of investigations and associated CAPA teams across all functional areas. Leads teams and drives improvement where CAPA resolution is required.
• Actively works with investigation teams to ensure on-time completion of investigations and CAPA(s).
• Provides direction, coaching, and support to investigation teams to ensure consistent application of root cause analysis tools and development of CAPA(s).
• Responsible for authorship and revision of quality related procedures.
• Responsible for quality review and/or approval of MBRs, procedures and documentation revisions.
• Provide quality leadership on project and/or risk assessment teams.
• Works independently with minimal guidance; Uses knowledge and expertise to develop other team members.
• Implements and oversees continuous improvement projects within QA Operations and support areas.
• Supports the site by participating in internal/external inspections and audits.

Education/Experience/ Licenses/Certifications:

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent, is required.
• Four years of related experience in the pharmaceutical or biologics industry is required.

Specific Knowledge, Skills, Abilities, etc:

• Knowledge of biologics manufacturing is preferred.
• Demonstrated knowledge of US and EU cGMP regulations and guidance.
• Experience with cGMP documentation review is required.
• Experience with Regulatory agencies and inspections is preferred.
• Experience with Human Error investigations and Root Cause Analysis tools is highly preferred.
• Individual must be able to communicate clearly and succinctly, both verbally and in writing.

Physical Demands & Work Environment:

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

Work Location:

East Syracuse, NY 

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! 

http://www.lottebiologics.com/

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.