Senior Quality Assurance Specialist II (Swing Shift) PC 1607

Miltenyi Biotec•Gaithersburg, MD

30d

About The Position

Your Role: The role is responsible for driving and building quality assurance in a GMP multi-product facility. The Senior QA Specialist II provides quality assurance oversight for GMP manufacturing operations to ensure compliance with regulatory requirements, internal procedures, and quality standards. This role supports QA on-the-floor activities, batch record review, and quality system processes during swing shift operations, ensuring manufacturing activities meet cGMP, FDA, and company quality requirements. This position is also responsible for, reviewing and approving Environmental Monitoring and, lot disposition, line clearance and inspecting, reviewing, and dispositioning raw materials, reagents and components. This position represents Quality at cross functional team meetings and client meetings. This position will also assist the Quality Engineering team with review and approval of validation and facilities protocols, reports and documentation.

Requirements

Bachelor’s degree in Biology, Microbiology, Biotechnology, Chemistry, or related life science discipline.
Minimum of 8 years of cGMP experience with at least 6 years in Quality Assurance in life sciences and late-stage biopharma industry.
Strong experience with QA on-the-floor support and batch record review.
In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
Clear understanding of standards of practice used in the manufacture of biotechnology products
Experience in cell therapy products effectively supporting FDA inspections, EU regulators and client audits.
Ability to work a swing shift schedule.
Excellent verbal, written, interpersonal, organizational and communication skills.
Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
Experience with batch record review and documentation control.
Experience supporting manufacturing floor operations (QA on the floor).
Experience with deviation investigations, CAPA, and change control systems.
Strong communication and cross-functional collaboration skills.
Ability to support swing shift operations and occasional weekend work.

Responsibilities

Provide QA on-the-floor oversight during swing shift manufacturing operations, ensuring compliance with approved procedures, batch records, and regulatory requirements.
Support real-time manufacturing activities, including line clearance verification, material verification, and monitoring of critical manufacturing steps.
Perform review of batch records for final product, in-process testing, QC release testing data packages, labeling, packaging, and all supporting documentation.
Inspect, review, and disposition raw materials, reagents and components.
Coordinate release final cell-based therapeutic products.
Identify and escalate quality issues, deviations, and compliance risks during manufacturing operations.
Participate in deviation investigations, assist with root cause analysis, and support development and implementation of Corrective and Preventive Actions (CAPA).
Develop and maintain quality operations processes to support the development, establishment and maintenance of effective procedures to support Quality operations that complies with applicable GMP standards, regulations, and guidelines.
Support the implementation of requirements for commercial manufacturing.
Collaborate with QC and other units to develop, improve and maintain routine environmental monitoring (EM) program for the controlled environment rooms, review trend analysis reports, participate in investigations, and oversee in process and personnel monitoring performed during aseptic processing operations.
Take a proactive role for continuous improvement and lead QMS improvement projects and management review.
Write and revise SOPs and specifications, as needed, and review and approve cGMP documentation including procedures, protocols, reports, CAPAs, technical data and risk assessments.
Assist with internal audits, regulatory inspections, and audit readiness activities.
Monitor and trend quality metrics and quality events to support continuous improvement initiatives.
Provide GMP guidance and training support to manufacturing personnel during shift operations.
Maintain clear documentation and communication of shift quality activities and quality events.