Quality Oversight Specialist

Stallergenes Greer Ltd; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

Stallergenes Greer is seeking a Quality Oversight Specialist to provide real-time quality oversight in aseptic manufacturing areas, ensuring GMP compliance and data integrity. The role partners with operations to maintain production goals while upholding high standards of quality and patient safety.

The specialist will review batch records and room clearances, support investigations, and assist audits and inspections, contributing to a culture of quality and continuous improvement across

Qualifications

• Bachelor’s degree in biological sciences or engineering preferred, or equivalent education/experience.
• Minimum 2 years in a QA role within a GMP pharmaceutical or biotech manufacturing environment.
• Strong understanding of biotechnology manufacturing (e.g., sterilization, aseptic processing).
• Solid knowledge of GMP, data integrity, manufacturing operations, and contamination control principles.
• Strong communication, problem-solving, and decision-making skills.
• Ability to remain calm, objective, and effective in fast-paced environments.
• High attention to detail and commitment to product quality, patient safety, and compliance.

Responsibilities

• Serve as the primary on-the-floor Quality presence in critical manufacturing areas.
• Provide immediate GMP, documentation, and aseptic behavior guidance to operators and supervisors.
• Perform real-time review of manufacturing documents to minimize errors and delays.
• Release aseptic areas daily after review of cleaning records and room clearance.
• Identify and promptly elevate potential risks and support real-time issue triage.
• Ensure rapid, compliant resolution of on-the-floor quality questions.
• Partner with operations and other teams to support investigations.
• Observe manufacturing activities to ensure consistent application of ALCOA+ and contamination control strategies.
• Support internal audits, regulatory inspections, and readiness activities through documentation review and follow-up actions.
• Identify opportunities to streamline processes while maintaining quality and compliance.

Skills

Quality oversight

GMP knowledge

Data integrity

Problem solving

Communication

Decision-making

Cross-functional collaboration

Education

Bachelor’s degree in biological sciences or engineering

Job description

The Quality Oversight Specialist provides real-time quality oversight in aseptic manufacturing areas to ensure operations meet GMP, regulatory, and site quality standards. This role delivers immediate quality support, promotes a strong quality culture, and partners with operations to achieve production goals while maintaining compliance. Responsibilities include proactive issue identification, timely decision support, and reinforcing high standards of quality, data integrity, and compliance.

Key Responsibilities

Quality Oversight & Support

• Serve as the primary on-the-floor Quality presence in critical manufacturing areas.
• Provide immediate GMP, documentation, and aseptic behavior guidance to operators and supervisors.
• Perform real-time review of manufacturing documents (batch records, logbooks, sampling, equipment use) to minimize errors and delays.
• Release aseptic areas daily following review of cleaning records and room clearance.

Issue Identification & Decision Support

• Identify and promptly elevate potential risks (e.g., deviations, contamination risks, process issues).
• Support operations with quality-focused, solution-driven real-time issue triage to maintain product quality and production flow.
• Ensure rapid, compliant resolution of on-the-floor quality questions.
• Partner with operations and other teams to support timely, thorough investigations.

Monitoring & Compliance Activities

• Observe manufacturing activities to ensure consistent application of GMP (ALCOA+) and contamination control strategies.
• Support internal audits, regulatory inspections, and readiness activities through documentation review, media fills, Gemba walks, and follow-up actions.
• Identify opportunities to streamline processes while maintaining quality and compliance.
• Contribute to initiatives that improve documentation accuracy, reduce deviations, and enhance operational excellence.

Requirements

Required Qualifications

Education

• Bachelor’s degree in biological sciences or engineering preferred, or equivalent education/experience.

Experience

• Minimum 2 years in a QA role within a GMP pharmaceutical or biotech manufacturing environment.
• Strong understanding of biotechnology manufacturing (e.g., sterilization, aseptic processing).
• Solid knowledge of GMP, data integrity, manufacturing operations, and contamination control principles.
• Strong communication, problem-solving, and decision‑making skills.
• Ability to remain calm, objective, and effective in fast‑paced environments.
• High attention to detail and commitment to product quality, patient safety, and compliance.
• Ability to collaborate cross‑functionally while maintaining independence in quality decisions.

Physical Requirements

• Ability to sit and stand for extended periods.
• Ability to stand and/or walk on concrete floors for 8–10 hours per day.
• Ability to move safely within manufacturing environments, including donning appropriate PPE within classified cleanrooms and wearing required PPE (gowning, safety eyewear, gloves, etc.).
• Ability to lift or maneuver materials or equipment up to 25 lbs as required.

About STALLERGENES GREER International AG

Stallergenes Greeris an international biopharmaceutical company specialized in the research, diagnosis and treatment of respiratory,food and venom allergies through the development and marketing of Allergenic Immunotherapy treatments.

Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.

Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re‑education of the patient’s immune system by inducing an increasing tolerance to allergens.

With more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 44countries.

Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment?

This position requires the following for employment at Stallergenes Greer and includes but not limited to:

A successful candidate will lead, manage, develop, and retain a team of planners to ensure that every part of the production process is aligned to meet the company's goals, customer needs, and