Quality Assurance Specialist

Quality Assurance Specialist I develops and implements company and regulatory quality standards in the manufacturing facility. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist I audits and reviews quality data according to existing documents and procedures. May require an associate degree or its equivalent. Additionally, Quality Assurance Specialist I typically reports to a manager. The Quality Assurance Specialist I works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Quality Assurance Specialist I typically requires 0-2 years of related experience.

Quality Assurance Specialist Job Description Template

Our company is looking for a Quality Assurance Specialist to join our team.

Responsibilities:

  • Author, review and approves GMP procedures and validation deliverables;
  • Develops and maintains quality agreements;
  • Review and approve batch records in support of product release;
  • Advises in development of metrics and KPIs for approved QMS;
  • Assess timelines for QA testing tasks & meeting timelines for projects;
  • Prioritize and manage a variety of projects simultaneously;
  • Test using both manual and automated tools and reports;
  • Work closely with and follow direction from QA Manager;
  • Independently identify and manage special projects;
  • Conduct walk through and internal audits of site warehouses;
  • Responsible for performing batch record review, room/line clearances, report writing and auditing;
  • Document results of account audits;
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues;
  • Perform root cause investigations related to Non conformance, Deviations and Customer Complaints;
  • Incumbent will work closely with the CIS Quality Assurance group for the maintenance and management of the Quality Management System (QMS).

Requirements:

  • Often – Reaching, Standing, Sitting, Walking, Pushing, Pulling, Talking, Hearing, Seeing;
  • University degree or equivalent experience;
  • Advanced level cGMP environment and related QA field;
  • Working knowledge of private doctor community, managed vision care and optical terminology/process;
  • Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, Outlook, and/or MS Access);
  • Ability to independently manage multiple priorities and projects;
  • Knowledge and experience in CBRN material as well as an understanding of the hazards associated with their manufacture, transport and use;
  • Knowledge of designing, planning, and implementing training related materials in an ambulatory call center setting;
  • Demonstrated excellent written and oral communication skills;
  • Ability to obtain high-level clearance and DHS suitability clearance;
  • Bachelor’s degree in Biology, Microbiology, Immunology, Molecular Biology or related field;
  • Master’s degree in Biology, Microbiology, Immunology, Molecular Biology or related field;
  • Serve as member of Material Review and Configuration Control Boards;
  • Effectiveness and creativity in approaching and solving technical problems;
  • Outstanding written and verbal communication skills.