Staffing Solutions Enterprises · 1 day ago
Part Time QA Documentation Specialist
Cleveland, OH
Full-time, Part-time
Onsite
Entry Level
$20/hr - $23/hr
1+ years expStaffing Solutions Enterprises is seeking a dedicated Part Time QA Documentation Specialist to support their quality team in maintaining and organizing critical documentation for medical devices. This role is essential for ensuring compliance with cGMP standards and involves tasks such as maintaining records, reviewing documentation, and collaborating with team members to achieve departmental goals.
Human ResourcesInformation Technology
Responsibilities
Maintain both hard copy and electronic records of SOPs, Specifications, Test Methods, Protocols, and Validation documents, converting files to PDF as needed
Review and assist with the development, revision, and approval of documentation, ensuring proper formatting and completeness
Manage databases of electronic forms, Device History Records (DHR), CAPA, Nonconformances, Deviations, and ECRs
Support complaint handling by maintaining records, organizing defective product replacements, and assisting with trend analysis
Issue, review, and release Device History Records for finished devices
Keep training records current and accurate, both digitally and in hard copy
Oversee the electronic Approved Supplier List (ASL) and support hazardous waste area monitoring
Serve as a backup for QA testing and line clearance during production runs
Collaborate proactively with team members to achieve departmental goals while adhering to safety policies
Qualification
Required
Strong organizational skills with meticulous attention to detail
Excellent verbal and written communication abilities
Proficiency in Microsoft Office Suite and general PC skills
Ability to manage multiple projects efficiently
Prior administrative or customer service experience (1-3 years)
Preferred
Experience with document management systems
Familiarity with medical device regulatory compliance
Experience in trend analysis related to quality and customer complaints
Background in quality assurance or regulatory documentation in the medical device or pharmaceutical industry
Company
Staffing Solutions Enterprises
Staffing Solutions Enterprises is a staffing and recruiting company that offers contract and permanent staffing solutions.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase