Specialist, QA Operations Shopfloor

Qabird; Leiden; On-site; EUR 35,000 - 50,000; Full time

Job summary

Qabird in Leiden is seeking a Specialist, QA Operations Shopfloor to ensure compliance with manufacturing and quality control processes. In this role, you will oversee operations and maintain adherence to quality standards while supporting both internal and external inspections.

The ideal candidate should have a bachelor's degree in engineering or a related field, with 0–2 years of experience in cGMP. Proficiency in electronic systems and a focus on detail are essential for success in this fast-paced environment.

Qualifications

• Bachelor's degree in engineering, life or physical science preferred.
• 0–2 years of relevant cGMP experience; FDA/EMA regulations experience is preferred.
• Experience with quality management systems is also preferred.

Responsibilities

• Provide quality oversight to Manufacturing, QC, Warehouse, and Packout operations.
• Identify and respond to discrepancies and operational issues.
• Perform area walkthroughs to ensure adherence to cGMP.

Skills

Problem-solving skills

Effective communication

Detail-oriented

Teamwork

Active listening

Education

Bachelor's degree in engineering or related field

High school diploma or Associate’s degree with relevant experience

Tools

Manufacturing Execution Systems (MES)

Enterprise Resource Planning (ERP)

Job description

Position Summary

The Specialist, QA Operations Shopfloor oversees and partners with Manufacturing, Quality Control laboratories, and Warehouse Operations to ensure compliance with Bristol Myers Squibb policies, standards, procedures, and Global current Good Manufacturing Practice (cGMP).

Key Responsibilities

• Provide quality on-the-floor oversight to Manufacturing, QC, Warehouse and Packout operations.
• Identify departures from approved procedures and respond to issues independently, escalating more complex issues to senior members.
• Independently assess discrepancies for entry into the quality system and approve deviations, as applicable.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return-to-service plans.
• Perform area walkthroughs to identify quality issues, propose remediations and support implementation to ensure the floor and operations adhere to cGMP and approved procedures.
• Review manufacturing or testing records to ensure compliance with approved procedures.
• Communicate and resolve discrepancies independently and elevate as required.
• Author and review department-owned documents.
• Maintain compliance with assigned learning plan.
• Support integration of newer team members.
• Support internal and external inspections as required.
• Participate in cross-department and cross-functional meetings, communicate in a professional manner, and share data and knowledge within the team.
• Build relationships with specialized functions.

Key Competencies

• Ability to understand, follow and apply approved procedures.
• Proficient computer skills, including MS Office.
• Ability to understand problems and propose practical solutions.
• Ability to communicate effectively with cross‑functional peers and various levels of management through written and verbal skills.
• Ability to work in a fast‑paced team environment with changing priorities.
• Detail oriented and task‑focused with ability to meet deadlines and prioritize assigned work.
• Active listening skills and ability to understand varied perspectives.
• Ability to independently make decisions and recognize the need for escalation of issues.
• Ability to seek out opportunities for improvement.

Qualifications & Experience

• Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) is preferred. High school diploma or Associate’s degree with an equivalent combination of education and work experience is acceptable.
• 0–2 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Experience with quality management systems is preferred.
• Experience with electronic systems and databases such as Manufacturing Execution systems (MES) and Enterprise Resource Planning (ERP) is preferred.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and ongoing support in their roles. Applicants can request a reasonable accommodation prior to accepting a job offer. For assistance, contact [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

R1602744: Specialist, QA Operations Shopfloor