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Quality Assurance Specialist

Job Description

 Quality Assurance Specialist 

We are looking for a detail-oriented Quality Assurance Specialist to assist the Site QA and Corporate QA in the site’s quality assurance activities. The Quality Assurance Specialist's responsibilities include assisting in the development and implementation of quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions.

To be successful as a Quality Assurance Specialist you should be incredibly thorough and able to help our company maintain the highest quality standards.

Quality Assurance Specialist Responsibilities:

  • Preparing and implementing quality assurance policies and procedures.
  • Performing routine inspections and quality tests.
  • Identifying and resolving workflow and production issues.
  • Ensuring that standards and safety regulations are observed.
  • Addressing and discussing issues and proposed solutions with superiors.
  • Documenting quality assurance activities and creating audit reports.
  • Maintaining site documentation.
  • Preparing documentation and materials required for batch production and QC.
  • Material acceptance and creation of material specification sheets. 
  • Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
  • Maintain employee training binders.
  • Assist Site and Corporate QA in internal audits and making recommendations for improvement.
  • Creating training materials and operating manuals as requested by Site and Corporate QA.
  • Liaise with external inspectors, CMO representatives, particularly on QA-related topics and take minutes of meetings, if requested.
  • Assist in the oversight of the metrology program at the site. (equipment/personnel qualifications/validations, etc.)

Assist as required with all other site QA activities not otherwise listed above.

Attend quality related meetings and conference calls. Interface with Corporate QA on quality related issues. Provide any status updates as required by Corporate QA.

Quality Assurance Specialist Requirements:

  • High school diploma/GED required.
  • Degree preferred.
  • Certificate in quality assurance is a plus.
  • Previous experience in quality assurance or similar field.
  • Working knowledge of tools, methods, and concepts of quality assurance.
  • Proficiency in Microsoft Office Applications.
  • Solid knowledge of relevant regulatory standards.
  • Good communication skills, both verbal and written.
  • Excellent data collection and analysis skills.
  • Strong attention to detail.
  • Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals or technical procedures.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. 
  • Ability to solve problems and effectively communicate in-person and on the phone.
  • Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.