What are the responsibilities and job description for the Quality Assurance Specialist I position at Intellectt Inc?
Role: QA Specialist I
Location: Scarborough, ME - 04074
Duration: 8 Months
Job Summary:
Seeking a Quality Assurance Specialist I to support product quality, process improvements, and quality system programs within a manufacturing environment. This role involves reviewing production records, conducting audits, and ensuring compliance with quality standards.
Key Responsibilities:
- Review production batch records (DHRs) for accuracy and completeness
- Approve intermediate and finished products for release
- Identify, document, and resolve deviations in production records
- Perform spot-check inspections and audits of production operations
- Develop and maintain Standard Operating Procedures (SOPs)
- Assist in testing complaint and stability samples; report out-of-spec results
- Initiate and track Quality Incidents (QI) and CAPA activities
- Support document control systems (eDCS)
- Manage or assist with sample retention and stability programs
- Provide backup support to other quality team members
Required Qualifications:
- Bachelor’s degree in Chemistry, Biology, Life Sciences, or related technical field
- 1 year of experience in Quality Assurance or manufacturing support
Preferred Qualifications:
- Experience in Quality Assurance within the medical device or regulated industry
Key Skills & Competencies:
- Strong attention to detail and documentation accuracy
- Ability to follow and interpret procedures, manuals, and instructions
- Familiarity with quality systems, CAPA, and deviation handling
- Proficiency in MS Excel and Word
- Strong analytical and problem-solving skills
- Ability to write reports and communicate effectively
- Basic mathematical and data interpretation skills