Senior Quality Assurance Specialist
SGS North America Inc.

Fairfield, New Jersey

Posted in Consultancy


This job has expired.

Job Info


Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

The Senior Quality Assurance Specialist duties are geared toward assisting Quality Assurance Management in administering the company's quality system. This is accomplished through internal audit performance and reporting, Operations Manual System management, Form Control System management, and participation in various quality improvement projects. Overall, the Senior Quality Assurance Specialist position presents the employee with an opportunity to both learn the skills required to advance in the management field of quality assurance and at the same time play a crucial role in the company's long-term success.
This position presents the employee with an opportunity to contribute first-hand to the process of providing quality data to the SGS customer base.

  • Participate in the approval of Out of Specification events, deviations, and special assessments to ensure compliance with current regulatory standards.
  • Participate or oversee the approval of routine testing, special projects, validation projects, or other specialized studies to ensure successful completion in a timely and effective manner.
  • Assist in handling company complaints in an efficient and timely manner.
  • Respond to all customer requests for information pertaining to regulatory and compliance issues in a timely and accurate manner.
  • Play a lead role in departmental and/or company-wide projects designed to improve customer service.
  • Assist Management in addressing and resolving Corrective or Preventive actions.
  • Assist in the conduct of customer audits and in writing responses to audit reports.
  • Assist the Team Leader or Quality Assurance Management in fielding questions and resolving issues that arise internally within the Quality Assurance team.
  • Provide updates to Quality Assurance Management concerning assigned projects.
  • Assist the Team Leader or Quality Assurance Management in coordinating the training program and providing training within the Quality Assurance team.
  • Play a lead role in becoming a key department source on regulatory issues both to laboratory personnel and internally within the Quality Assurance team.
  • Assist Senior Management in administering the company's Quality Planning effort.
  • Assist Quality Assurance Management in audit planning, performance, follow-up procedures, and/or corrective action.
  • Respond to all reasonable staff requests for information pertaining to regulatory affairs.
  • Assist in the performance of the internal audit program.
  • Maintain thorough knowledge and understanding of all general SOPs pertaining to the laboratory.
  • Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory.
  • Assist in the review and approval of deviation notices and investigations generated by technical departments.
  • Assist management in overseeing the investigation system for all technical departments.
  • Assist Management in auditing specific aspects of the company's ISO quality systems, report all findings to senior management, issue corrective action plans, and verify effective corrective action.
  • Assist Management in core GLP functions as they relate to Quality Assurance.
  • Assist Management in the review and approval process for company SOPs.
  • Assist Management in maintaining the company's Change Control System.
  • Assist Management in assigned Quality trending.
  • Approve and issue Certificate of Analysis and sign on cGMP related reports.


Qualifications

  • Bachelor of Science in Chemistry, Biology, or related sciences
  • 5+ years experience in a regulated, commercial lab environment
  • Solid organizational skills required; must be able to prioritize multiple tasks
  • Knowledge of Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) / ISO regulations & standards
  • Must be able to obtain and assess objective evidence fairly
  • Strong communication skills (written and verbal) essential
  • Strong leadership skills required; must be able to form a consensus among others



This job has expired.

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