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.
- 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).
- 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.