Quality Validation Specialist

Net2Source Inc.; Durham (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Specialist in Quality Assurance to lead critical projects in the Pharmaceutical Manufacturing sector. This role involves ensuring compliance with regulatory standards, managing quality oversight for sterile manufacturing processes, and providing support for project delivery through comprehensive documentation reviews. With a focus on interpersonal and communication skills, the ideal candidate will thrive in a collaborative environment, engaging with cross-functional teams to uphold the highest quality standards. If you are passionate about quality assurance and eager to make a significant impact in the pharmaceutical industry, this opportunity is for you.

Qualifications

• 5+ years of experience in Quality Assurance within the Pharmaceutical Industry.
• Strong knowledge of regulatory expectations for sterile pharmaceutical products.

Responsibilities

• Manage project assignments in Quality Assurance independently.
• Ensure compliance with cGMP, regulations, and the company's Quality Management System.

Skills

Quality Assurance

Regulatory Compliance

Interpersonal Skills

Communication Skills

Negotiation Skills

Education

Bachelor's in Biology

Bachelor's in Microbiology

Bachelor's in Pharmacy

Bachelor's in Chemistry

Bachelor's in Chemical Engineering

Tools

GMP Documentation

Quality Management System

Job description

Title: Senior Specialist Quality Assurance

Duration: 12 months

Pay Rate: $50 - $55.00/hr on W2

Note: Start date for this role is June 16th, 2025.

Qualifications:

Quality Assurance professional with a minimum of a BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent, and at least 5 years of experience in the Pharmaceutical Industry.

Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products, with experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.

Must have 3 years of experience with development, review, and approval of User Requirement Specifications (URS), Factory Acceptance Tests (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities, and utilities.

Responsibilities:

Preferred experience in assessing and preparing manufacturing sites for Pre-Approval inspections by regulatory agencies for new products.

• Reporting to the Quality Assurance Organization, will independently manage project assignments.

• Must demonstrate strong interpersonal, communication, negotiation, and persuasion skills, with excellent relationship-building abilities.

• Provide immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.

• Offer QA support including critical/review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch records to meet schedule milestones.

• Ensure all project aspects comply with cGMP, regulations, and the company's Quality Management System.

• Focus on qualification and compliance areas covering manufacturing equipment such as isolators, restricted access barriers, incubators, washers, autoclaves, formulation vessels, lyophilizers, etc.

• Review and approve master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports.

• Consult with higher management on complex decisions as needed.

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Other

Industries: Pharmaceutical Manufacturing