Quality Specialist

3 weeks ago

Smyrna, United States Randstad Sourceright Full time

Primary Purpose / Regulatory Responsibilities:

The goal of this function is to support the Quality Management Systems in the U- U.S. Affiliate, including but not limited to the following:

  • Ensure global quality practices are integrated in the affiliate to ensure compliance is met regarding U- and local regulations.
  • Maintain the GXP status of the affiliate in accordance with national and international GMP and legal requirements.
  • Ensure QA deliverables are achieved in a compliant timely manner.
  • Support Local Quality Lead in tasks.

MAJOR RESPONSIBILITIES

  • Ensure implementation and maintenance of the local Quality Management System elements listed below to drive compliance of all relevant cGXPs with local/International regulatory requirements and U- global standard operating procedures.
  • Quality Management Review
  • Quality System Monitoring
  • Document and Record Management
  • Deviation Management
  • Investigation Process
  • CAPA Management
  • Change Control Management
  • Product Complaint Management
  • APQR
  • Local Vendor Management
  • Product Returns


Others

  • Provide support, as deemed necessary, to the Quality Lead and Quality Partners or execute the QMS tasks not listed above under oversight from the Quality Lead or Quality Partners.
  • Ensure Quality deliverables listed above are completed in a timely manner in accordance with Corporate QMS and KPIs.
  • Ensure efficient information flow and effective communication of quality matters within the relevant Affiliate organization to the Quality lead including but not limited to issue escalation.
  • Support ad-hoc projects at the affiliate, as needed.
  • Support Global projects on quality systems, as needed.


Education Level

Bachelor's Degree, preferably in Biological or Chemistry Science


COMPETENCIES

  • Ability to effectively interact with and influence internal personnel on product and quality related matters.
  • Possess excellent interpersonal, verbal, and written communication skills.
  • Ability to manage complexity and multitask.
  • Ability to analyze data and information to draw conclusions and make effective decisions and escalate as required.
  • Self-motivated team player, who can support new ideas.
  • The ability to work effectively with minimum supervision.
  • Possess root cause and risk management/assessment skills.
  • Fluent and confident use of English language verbally and in reading & writing.
  • Experience using Microsoft Office Suite applications (e.g., Excel, PowerPoint, Word).
  • Working knowledge of specific applications is desirable (e.g., Veeva, SAP, Trackwise, QlikSense).

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