Quality Assurance Specialist I

Intellectt Inc; Scarborough (ME); On-site; USD 50,000 - 70,000; Full time

Job summary

A manufacturing firm in Scarborough, Maine, is seeking a Quality Assurance Specialist I to support product quality and process improvements. Responsibilities include auditing production records, managing quality incidents, and ensuring compliance with quality standards. Candidates should hold a Bachelor’s degree in a related field and have over a year of experience in Quality Assurance or manufacturing support. Attention to detail, strong analytical skills, and proficiency in MS Office are essential for success in this role.

Qualifications

• 1+ year of experience in Quality Assurance or manufacturing support.
• Experience in Quality Assurance within the medical device or regulated industry preferred.

Responsibilities

• Review production batch records 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.

Skills

Attention to detail

Analytical skills

Problem-solving skills

Communication skills

MS Excel

MS Word

Education

Bachelor’s degree in Chemistry, Biology, Life Sciences, or related technical field

Job description

Overview

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
• 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
• 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