Overview
Quality Assurance Specialist Jobs in Haverhill, MA at Harba Solutions Inc.
Title: Quality Assurance Specialist
Company: Harba Solutions Inc.
Location: Haverhill, MA
Key Responsibilities
Actively promote adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and compliance standards.
Assist with the release process for incoming raw materials.
Collaborate with Supply Chain and Manufacturing teams to dispense raw materials for batch production.
Support Quality Control (QC) and Analytical Research and Development (ARD) by reviewing, approving, and filing Certificates of Analysis (CoAs).
Oversee clinical phase manufacturing to ensure GMP compliance, including issuing production batch records, conducting line clearances, maintaining a QA presence on the floor, and performing checks on raw materials, components, and in-process materials.
Review batch documentation, address deviations and investigations, manage change controls, and resolve issues related to Intermediate and Drug Product (DP) disposition.
Contribute to document lifecycle and training management, such as initiating documents, assigning numbers, revising content, approving distributions, and maintaining training records.
Review documents for consistency, completeness, formatting, and adherence to templates.
Develop and maintain standardized templates for various document types.
Support the maintenance of employee training records and build department curricula.
Actively engage in continuous improvement initiatives for quality systems.
Qualifications
Bachelor’s degree (BA/BS) in a science-related field.
2-6 years of relevant experience in the pharmaceutical, biotech, or medical device industries.
Strong knowledge of GMPs, GDPs, and their application in pharmaceutical development.
Experienced with Cell/Gene Therapy & AAV manufacturing is preferred.
Proficient in Microsoft Word, Excel, PowerPoint, SharePoint, and Smartsheet.
Excellent organizational, verbal, and written communication skills, with the ability to manage multiple tasks effectively.
Strong interpersonal skills and a collaborative mindset to work efficiently in a team environment.
Adaptable and flexible in response to changing circumstances and priorities.
Skilled in troubleshooting and problem-solving.
