GMP QC Compliance Specialist

Job not on LinkedIn

🔥 9 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Pace® Labs

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Pace® Labs is a nationwide network of laboratories and professional services that provides analytical and environmental testing, life‑sciences CDMO/CRO and central laboratory services, building‑science and laboratory support, and emergency response for contamination and outbreak events. The company delivers environmental sampling and testing (air, water, soil, PFAS, Legionella, VOCs, metals, radiochemistry, etc. ), GMP analytical testing and formulation/clinical manufacturing support for pharma and biopharma, medical device testing and regulatory/compliance consulting, plus instrument, cleanroom and facility services to regulated industries.

📋 Description

• Serve as the primary compliance authority and QC subject matter expert for mRNA and biologics laboratory operations • Ensure analytical and quality control activities comply with GxP regulations, internal quality standards, and global regulatory expectations • Monitor regulatory developments, assess operational impact, and implement required changes • Conduct GxP compliance assessments and lead remediation efforts • Author, review, and approve QC sections of regulatory submissions, including CTD Module 3 content, INDs, BLAs, MAAs, and post-approval variations • Coordinate QC documentation with Regulatory Affairs and respond to regulatory questions and deficiencies • Own and maintain QC processes within the site quality management system • Oversee controlled documents, SOPs, methods, specifications, protocols, and reports in the eDMS • Track QC compliance metrics and KPIs and present findings to quality leadership • Lead QC inspection readiness, audits, self-inspections, audit responses, CAPAs, and follow-up activities • Design and maintain GxP training and competency programs for QC personnel • Lead QC change control, deviation, non-conformance, root-cause analysis, and CAPA activities • Champion data integrity and oversee assessments, audit trails, raw data verification, and system controls • Ensure LIMS, CDS, ELN, and instrument software comply with applicable validation and data integrity requirements • Manage QC supplier qualification, monitoring, audits, Certificates of Analysis, and approved supplier records • Mentor QC staff and collaborate with QC, QA, Regulatory Affairs, HR, Procurement, and Supply Chain teams

🎯 Requirements

• Minimum 5 years of progressive experience in pharmaceutical or biopharmaceutical QC, Quality Assurance, or a combined QC/QA compliance role • Experience supporting QC laboratory operations in a GMP-regulated biologics or mRNA environment • Proven experience managing regulatory inspections and internal audits within a QC laboratory setting • Hands-on experience with deviation management, CAPA systems, change control, deviation investigations, and quality management systems in a regulated pharmaceutical environment • Experience authoring and reviewing GxP-compliant documentation, including SOPs, validation protocols/reports, and regulatory submission content • In-depth knowledge of FDA 21 CFR Parts 211 and 600–680 • Knowledge of EU GMP Guidelines Annexes 1, 2, 11, and 15 • Knowledge of ICH Q2(R2), Q6B, Q10, Q11, and Q14 • Knowledge of PIC/S guidelines • Strong understanding of data integrity principles and regulatory expectations • Knowledge of GMP, GDP, and GLP requirements for analytical laboratory operations • Experience with mRNA and biologics analytical testing, product release, stability, and method lifecycle activities • Experience with LIMS, CDS, ELN, electronic document management systems, and instrument software • Knowledge of 21 CFR Part 11 and EU Annex 11 requirements • Experience with audit trail reviews, raw data verification, and system access controls • Experience with structured problem-solving methods such as Ishikawa, 5-Why, and Fault Tree Analysis

🏖️ Benefits

• Competitive salaries • Medical insurance • Dental insurance • Vision insurance • 401K retirement savings plan • Employer match is 100% vested immediately • Life insurance • Disability benefits • Voluntary benefits • Paid time off for holidays • Paid sick days • Paid vacation days • HSA • Wellness program • Flexible spending accounts • Tuition reimbursement • Employee Assistance program • Parental leave • Optional legal coverage • ID theft protection