Quality Assurance Specialist

Equiliem; Hazelwood (MO); Remote; USD 62,000 - 69,000; Full time

Benefits offered by this job

Medical Insurance

Vision & Dental Insurance

Life Insurance

Matching 401(k)

Commuter Benefits

Employee Discounts & Rewards

Payroll Payment Options

Job summary

Equiliem is seeking a Quality Assurance Specialist to support sterile injectable manufacturing and CMOs. The role focuses on batch record review, disposition, quality systems, and audit readiness across multiple sites, with remote work options and travel approx. quarterly.

You will ensure cGMP compliance (21 CFR Parts 210/211) and collaborate with cross-functional teams to resolve quality issues, manage deviations and CAPAs, and support product launches and technology transfers.

Qualifications

• 5+ years of pharmaceutical QA/ QC or related quality function
• 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 (21 CFR Parts 210/211)
• Experience with CMOs and supplier oversight is preferred
• Willingness to travel ~ quarterly

Responsibilities

• Review and approve CMO documentation for batch production
• Review batch records, investigate discrepancies, and elevate quality concerns
• 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

Skills

Quality Systems

cGMP Knowledge

Sterile Injectables

Documentation & Records

Supplier Oversight

Audit Readiness

Cross-Functional Collaboration

Education

Bachelor's degree in a scientific discipline

Job description

Quality Assurance Specialist

Location: Remote; preferred NJ/Northeast, East Coast, or Central Time Zone. Pay: $45.00 - $50.00 per hour

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 elevate 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.

Benefits

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

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.

EEO Employer

Equiliem is an equal opportunity employer. We do not discriminate or allow discrimination based on race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Equiliem will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [emailprotected] or [phone].