Quality Assurance Specialist

Quality Assurance Specialist
Location: Remote; preferred NJ/Northeast, East Coast, or Central Time Zone
Pay:$45.00 - $50.00 per hour
26-10672

Job Summary
The Quality Assurance Specialist supports externally manufactured pharmaceutical and biopharmaceutical products and serves as a key quality partner to contract manufacturing organizations (CMOs) and internal cross-functional teams. The role is responsible for batch record review and disposition, quality systems management, CMO oversight, stability program activities, audit readiness, and resolution of quality issues. The position requires strong knowledge of pharmaceutical quality systems and cGMP requirements, with particular emphasis on sterile injectable manufacturing. The Quality Assurance Specialist will also support continuous improvement, quality projects, and delegated initiatives while maintaining effective relationships with external manufacturing partners.

Job Responsibilities

• Review and approve CMO documentation associated with batch production.
• Review batch records, investigate discrepancies, and escalate quality concerns when appropriate.
• Prepare disposition and release certifications for reviewed batch records.
• Oversee third-party supplier activities related to product manufacturing, packaging, and testing.
• Maintain regular communication with CMOs to support timely manufacturing and resolution of quality issues.
• Monitor CMO product quality and performance.
• Manage quality records, including deviations, change controls, CAPAs, training records, and related documentation.
• Support cold-chain transportation qualification and routine monitoring activities.
• Support CMO maintenance activities and supplier qualification processes.
• Provide input into Technical Quality Agreements.
• Support post-launch quality activities across various countries.
• Manage delegated quality projects and initiatives.
• Review and approve stability protocols and stability data.
• Manage stability program activities and related documentation.
• Drive audit readiness activities to maintain compliance.
• Perform supplier audits as required.
• Support quality management system projects.
• Champion continuous improvement initiatives involving CMOs and internal quality operations.
• Support product launches, technology transfers, and validation activities as needed.
• Travel approximately once per quarter as required.

Job Requirements

• 5+ years of experience in pharmaceutical Quality Assurance, Quality Control, Technical Operations, or a related quality function; 7+ years preferred.
• Direct experience working with contract manufacturers or external pharmaceutical suppliers.
• Experience with batch record review and lot disposition.
• Experience managing quality systems, including deviations, change controls, CAPAs, training, supplier qualification, and document management.
• Sterile injectable pharmaceutical manufacturing experience required.
• Knowledge of cGMP requirements for pharmaceutical manufacturing, including 21 CFR Parts 210 and 211.
• Knowledge of 21 CFR Part 820, GDP, ISO 17025, and ISO 13485 is preferred.
• Experience reviewing stability data and protocols.
• Strong understanding of quality documentation and pharmaceutical manufacturing processes.
• Experience with CMO and laboratory oversight is preferred.
• Experience supporting product launches, technology transfers, or validation activities is preferred.
• Supplier audit experience is preferred; CQA certification is a plus.
• Medical device quality experience is a plus.
• Strong written and verbal communication skills.
• Ability to work independently and effectively within a cross-functional team.
• Strong attention to detail, organization, and follow-through.
• Ability to manage multiple priorities and complete work within established timelines.
• Willingness to travel approximately once per quarter.

Education

• Bachelor's degree in a scientific discipline required.

About Equiliem

Equiliem believes in empowering success. It's our job to cultivate relationships that connect people and employers in a way that is inclusive, intelligent, and allows both to thrive.

Across the U.S., leading companies in healthcare, government, engineering, manufacturing, professional services, and energy rely on us for their workforce solutions. Our recruiting and HR services include contract and direct hire staffing, Payrolling/EOR, Independent Contractor Compliance, and Managed Services.

For almost 30 years, we've helped shape our industry. Today, we continue to research, ask questions, and continuously enhance the candidate journey and client experience.

Benefits

We offer a comprehensive benefits package to our employees, which includes:

• Medical Insurance
• Vision & Dental Insurance
• Life Insurance
• Matching 401(k)
• Commuter Benefits
• Employee Discounts & Rewards
• Payroll Payment Options

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