Remote Quality Assurance Specialist — Pharma & CMO Oversight

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

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.