Quality Assurance Specialist II

SGS•Union, NJ

11h•$65,000 - $80,000•Onsite

About The Position

The Quality Assurance Specialist II, Cosmetics and Hygiene, assists with the standardization and harmonization, and continuous improvement of the quality management system, performs audits of internal processes according to ISO 19011 standards, support in regulatory audits, and remains knowledgeable of regulatory requirements and accreditation standards, including, but not limited to Good Clinical Practices, International Center for Harmonization, Food and Drug Administrations and ISO Standards. May participate in developing policies, procedures and methods to evaluate and improve the quality of products, materials, components and/or operations. Will primarily oversee clinical studies performed at the SGS Cosmetic and Hygiene, Union Site and may support studies performed at other North America sites. Ensure compliance with the requirements of a quality management system to demonstrate SGS’s ability to perform clinical trial studies on human subjects according to all applicable regulatory requirements and standards and ensure that deliverables consistently meet customer requirements. Ensure SGS Cosmetics and Hygiene Quality Manual is always adhered to for activities performed at SGS Union site and liaise with the Operational leaders regarding changes to its design and implementation. Actively participates in clinical study monitoring at SGS Union site along with active participation during audits that are led internally or by sponsors, or accreditation bodies. Conducts routine oversight of ongoing clinical studies by conducting real time reviews of clinical documentation from start to finish and timely escalations of events/non-compliances to management. Ensure Study completion timelines are met by implementing and monitoring key performance indicators (KPIs) and by collaborating constantly with cross-functional teams and SMEs during day-to-day operations. Self-motivated and agile to assess, organize competing priorities and execute tasks with utmost attention to Quality. Create cross-training course list for North America QA to ensure qualified back-up QA support.

Requirements

Bachelor’s degree in one or more of the following areas: Biology or Microbiology, Chemistry or Biochemistry, Business Administration, Quality Assurance, Regulatory Compliance, etc.
3+ years of experience as a Quality Assurance Professional
2+ years of experience in a Quality Assurance or Operational Leadership role
Working knowledge of GCP, GDP, GLP and ICH E6 standards
1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team
2+ year of experience in clinical monitoring
Excellent working knowledge of Good Clinical Practices and regulatory systems [ISO, FDA, ICH], standards and compliance/auditing techniques

Responsibilities

Assists with the standardization and harmonization, and continuous improvement of the quality management system.
Performs audits of internal processes according to ISO 19011 standards.
Supports in regulatory audits.
Remains knowledgeable of regulatory requirements and accreditation standards, including, but not limited to Good Clinical Practices, International Center for Harmonization, Food and Drug Administrations and ISO Standards.
May participate in developing policies, procedures and methods to improve the quality of products, materials, components and/or operations.
Primarily oversees clinical studies performed at the SGS Cosmetic and Hygiene, Union Site and may support studies performed at other North America sites.
Ensures compliance with the requirements of a quality management system to demonstrate SGS’s ability to perform clinical trial studies on human subjects according to all applicable regulatory requirements and standards.
Ensures deliverables consistently meet customer requirements.
Ensures SGS Cosmetics and Hygiene Quality Manual is always adhered to for activities performed at SGS Union site and liaises with Operational leaders regarding changes to its design and implementation.
Actively participates in clinical study monitoring at SGS Union site.
Actively participates during audits that are led internally or by sponsors, or accreditation bodies.
Conducts routine oversight of ongoing clinical studies by conducting real time reviews of clinical study documentation from start to finish.
Timely escalations of events/non-compliances to management.
Ensures Study completion timelines are met by implementing and monitoring key performance indicators (KPIs).
Collaborates constantly with cross-functional teams and SMEs during day-to-day operations.
Assesses, organizes competing priorities and executes tasks with utmost attention to Quality.
Creates cross-training course list for North America QA to ensure qualified back-up QA support.