Job Description
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
Key skill Required
- Manufacturing
- Microsoft Office
- Quality Management
- Analytical Thinking
- Assurance
- Attention to Detail
- Biology
- Chemistry
- Communication
- Discipline
- Document Control
- Document Management
- Documentation
- Drafting
- Effective Communication
- Finished Goods
- Interpersonal Skills
- ISO Standards
- Management
- Management Systems
- Medical Device
- Optimization
- Organizational Skills
- Procedural Documentation
- Process Improvement
- Quality Assurance
- Quality Management System
- Regulatory Standards
- Supply Chain
- Technical Writing
- Work Instructions
- Writing
