Quality Assurance Specialist

We are seeking a Quality Operations Support Specialist to assist with documentation, quality systems, and process improvement initiatives within a regulated manufacturing environment. This role is ideal for someone with a background in quality assurance and strong technical writing skills, who thrives in a collaborative setting and enjoys working across teams to resolve quality concerns.

Responsibilities:

• Redline and initiate Finished Goods Specification creation and revisions
• Upload and maintain documentation in document control systems (e.g., MPRs, Specifications, BOMs)
• Route SOPs for review and approval
• Initiate and create records for External Deviations and Change Controls within eQMS
• Ensure timely documentation and tracking of quality events
• Draft and revise Work Instructions, Job Aids, and SOPs for the Finished Goods QA team
• Contribute to clear, compliant procedural documentation
• Partner with Manufacturing, Supply Chain, and Regulatory teams to resolve quality issues
• Support ongoing continuous improvement initiatives
• Ensure adherence to GMP , ISO , and other applicable regulatory standards
• Support optimization of processes within the Quality Management System (QMS)

Requirements

Qualifications:

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Engineering) or equivalent education/experience
• 13 years of quality assurance or quality operations experience in a regulated manufacturing environment (pharmaceutical, medical device, consumer goods, or food)
• Familiarity with GMP , ISO standards , and QMS tools
• Technical writing experience , including procedural documentation and SOP drafting
• Experience with document management systems such as Veeva or similar platforms
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
• Strong attention to detail, organizational skills, and analytical thinking
• Effective communication and interpersonal skills; must be able to understand and clearly communicate quality issues

Benefits

• Administrative shift
• 6-months contract