Intellectt Inc

Compensation

Full Description

Hello Job Seekers, This is Gaurav Senior recruiter from Intellectt Inc, I am looking for Visual Inspector in New York Area on W2 contract role. Please go through the job description and send me the updated resume as soon as possible. Job Description: Senior Quality Specialist (Contract) Location: Boston, MA (Hybrid) Position Type: Contract No Benefits Duration: 12 Months About the Role: We are seeking two experienced Senior Quality Specialists to join our team on a contract basis. This role is critical for providing quality assurance and compliance support for our developmental programs. The ideal candidate will have a strong functional knowledge of GMP regulations and will be responsible for ensuring the timely and compliant advancement of clinical products through the lifecycle. You will play a key role in batch disposition, quality system execution, and cross-functional collaboration. Key Responsibilities: Batch Record Review & Product Disposition: Perform detailed review of executed batch documentation (batch records, COAs, in-process controls, stability data) from internal and external manufacturers to support the disposition of drug substance, drug product, and finished goods. Quality Systems Management: Support or lead quality system processes, including: Deviation, Out-of-Specification (OOS), and Out-of-Trend (OOT) investigations, including root-cause analysis and CAPA identification. Change control assessment, implementation, and closure. Cross-Functional Collaboration: Represent Quality on cross-functional teams, effectively collaborating with colleagues from Pharmaceutical Sciences, CMC Regulatory, Supply Chain, and R&D Quality. Continuous Improvement: Identify and facilitate continuous improvement efforts within the Quality function. Documentation & Agreements: Support the drafting and revision of GMP documents, such as specifications, and Quality Agreements with CMOs and suppliers. Minimum Qualifications: Bachelor’s degree in a scientific or allied health field (or equivalent). Minimum of 5 years of relevant Quality Assurance work experience in a GMP pharmaceutical or biotech environment. Equivalent combination of education and experience will be considered. Preferred Qualifications: Operational Experience: Hands-on QA experience in an analytical or manufacturing setting, with a strong preference for small molecule manufacturing. Experience with biologics, devices, or gene therapy is a plus. Technical Skills: Proven proficiency in leading event investigations, Root Cause Analysis (RCA), and CAPA management. Regulatory Knowledge: Expanded conceptual knowledge of cGMPs and their application across the product lifecycle.