Our leading biotech client is hiring a Site Quality Specialist III to manage and oversee Quality Systems.
Daily Duties
Create, monitor, and analyze Site Quality Performance Metrics. When indicated, investigate, and initiate corrective actions and/or identify opportunities for improvements.
Collaborate with and support the Enterprise Document Control system to ensure appropriate administration, coordination and integration of document control and record management processes at the site.
Ensure SOPs and policies are assigned to facilitate initial and ongoing training for regulated and support staff roles.
Support site-specific Training and Competency, Change Management and Non- Conformity Programs as necessary to ensure compliance. Collaborate with staff and Program Leads to ensure appropriate, accurate, and timely records are completed and maintained.
Assess and assist in updating personnel records as necessary to ensure regulatory compliance.
Support External and Internal Audit Program. Act as subject matter expert in audits to answer questions on the Document Control Program and provide evidence to support compliance. Collect and organize documents in preparation for the audit. Help set up user credentials to provide access to the QMS for auditors as necessary. Assist Quality Lead and Auditor in coordinating audit activities, preparations, performance, and response to findings.
Support and collaborate with Laboratory Directors, Quality Team and Laboratory leaders to ensure ongoing audit readiness.
Assist with on time successful completion of external and internal proficiency surveys.
Collaborate with Site Lab Operations and Quality to ensure appropriate monitoring of laboratory performance.
Assist Quality, Operations and Regulatory Teams with process improvement initiatives and Quality Management System projects as necessary.
Collaborate and train Lab Operations and Operations Support teams to ensure they understand how to use Quality Systems and facilitate on time completion of assigned tasks (e.g. SOP updates).
Actively participate in Site Quality, Operations and Regulatory meetings. Bring quality concerns for discussion and follow up to ensure issues are effectively resolved.
Requirements
Bachelor’s degree in a relevant scientific discipline, required.
2+ years’ work experience in the biologics industry, preferably in a laboratory or IVD setting.
5+ years of quality assurance related work experience.
Experience working in a CLIA, CAP and NYS regulated facility (preferred).
Experience in a laboratory production or manufacturing environment.
Demonstrated proficiency with Microsoft Office and Google suite.
Strong communication skills and ability to effectively communicate with people of all levels.
Six sigma and RCA experience (preferred).
TCW Global is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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