Senior QC Compliance Specialist

Location: Harmans

Senior QC Compliance Specialist About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Position Summary We have an opportunity for a Senior QC Compliance Specialist to join our team supporting compliance in the Quality Control Analytical Laboratory. This role involves authoring, managing, and tracking investigations, events, deviations, and other quality records. The position also supports compiling, trending, and reporting key quality metrics for management accountability. The successful candidate will help ensure adherence to regulatory standards and continuous improvement of quality systems for GMP manufacturing of biological products.

Shift: Monday - Friday, 8am-5pm

Location:

Harmans, MD - BWI
100% Onsite

The Role Support and ensure timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.

Track and trend aspects of Quality Control Systems and provide management reports identifying risks and trends.

Collaborate with the Quality Systems group to perform QC CAPA effectiveness evaluations using quantitative and qualitative measures.

Maintain tracking mechanisms to support QC analytical metrics.

Monitor and review QC systems and procedures for compliance, quality improvements, and efficiency, providing compliance support to the QC department.

Participate in QC compliance remediation plans and implementation.

Assist with the generation and revision of GMP documentation such as standard operating procedures.

Establish and execute a laboratory audit readiness program to ensure continuous compliance.

Participate in QC internal audits as applicable.

Contribute to site quality and process improvement initiatives and represent QC Analytical on project teams.

Provide protocol generation and execution support for facility and utility qualifications and startups. Other duties, as assigned. The Candidate

Minimum Requirements Bachelor's degree in biology or other life sciences discipline with 3–5 years of experience in a quality or compliance function.

Experience with analytical and/or bioanalytical testing processes.

Knowledge of scientific and regulatory principles with the ability to enhance quality systems; exposure to Lean Operational Excellence methodologies is highly desirable.

Experience working in electronic systems such as Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), and Enterprise Resource Planning (ERP) systems is desirable.

Experience with Good Manufacturing Practices (GMPs).

Experience with the development, review, and approval of CAPAs, deviations, and investigations within the pharmaceutical or biologics industry, especially in analytical or bioanalytical laboratories.

Experience with International Council for Harmonisation (ICH) Guidelines, United States Pharmacopeia (USP), and European Union (EU) GMPs.Quick to learn and navigate electronic systems, with the…