Senior QA Engineer - Pharma Compliance & Improvement

MissionHires; Dallas (TX); Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

MissionHires seeks a Senior Quality Engineer for a fast-growing online pharmacy company. The role ensures compliance with FDA, state, cGMP, and USP requirements across pharmaceutical manufacturing and wholesale operations.

You will lead quality activities, approve documents, support audits, supplier quality, and drive continuous improvement within the quality management system. Collaborating with Engineering, Production, and Supply Chain, you will manage deviations, investigations,

Qualifications

• Bachelor's degree in engineering, life sciences, or related field; graduate degree preferred.
• Minimum 5 years of relevant experience in an FDA-regulated environment.
• Extensive knowledge of aseptic filling and pharmaceutical compounding.
• In-depth knowledge of cGMP requirements, including USP <797>, 21 CFR Part 211, and applicable guidelines, policies, and procedures.

Responsabilités

• Partner with Engineering, Production, and Supply Chain teams to ensure manufacturing and wholesale operations comply with applicable laws, regulations, site requirements, and quality standards.
• Serve as a technical quality expert, providing consultation, practical solutions, and compliance guidance to cross-functional stakeholders.
• Manage and support quality and compliance activities, including deviations, audits, customer complaints, escalations, and related investigations.
• Act as a Quality approver for Engineering and Validation activities.
• Author, review, and approve quality documentation, including regulatory communications, product specifications, policies, procedures, and records.
• Interpret and apply FDA, state, and industry requirements and best practices across operations.
• Provide Quality Management System oversight for ACE and the training program.
• Support the qualification, approval, and ongoing maintenance of suppliers.
• Collect, analyze, and communicate quality and operational data to identify risks, trends, and improvement opportunities.
• Maintain accurate, complete, and inspection-ready records and documentation.
• Build strong customer service relationships with internal and external stakeholders.
• Lead quality projects and cross-functional workstreams as needed.
• Train, orient, and review the work of peers to support consistent quality practices.

Connaissances

Quality management

Data analytics

Project management

Communication skills

Problem-solving

Training/Mentoring

Independent work

Formation

Bachelor's degree in Engineering/Life Sciences

Description du poste

MissionHires seeks a Senior Quality Engineer for a fast-growing online pharmacy company. The role ensures compliance with FDA, state, cGMP, and USP requirements across pharmaceutical manufacturing and wholesale operations.

You will lead quality activities, approve documents, support audits, supplier quality, and drive continuous improvement within the quality management system. Collaborating with Engineering, Production, and Supply Chain, you will manage deviations, investigations,