Quality Systems Specialist

About the role

The Quality Management System (QMS) Specialist is responsible for the administration, maintenance, and continuous improvement of the company’s Quality Management System to ensure compliance with current Good Manufacturing Practices (cGMP) and global regulatory requirements in a biotech environment.

Responsibilities

• Facilitate implementation, validation, and lifecycle management of GxP computerized systems, including eQMS and related quality platforms
• Partner cross-functionally with IT and system owners to ensure systems are configured, maintained, and controlled in compliance with internal procedures and regulatory expectations (e.g., 21 CFR Part 11, Annex 11)
• Provide system-related support to business units, including troubleshooting, user guidance, and continuous improvement initiatives
• Ensure data integrity principles (ALCOA+) are applied within quality systems and supported across system workflows
• Participate in system upgrades, changes, and integrations, ensuring appropriate change control, validation, and risk assessment activities are executed
• Actively promote a proactive, risk-based quality culture aligned with regulatory expectations and industry best practices.

Requirements

• BS/BA in life sciences or related field required
• Minimum of 2–5 years of experience in a quality assurance/quality control role within a regulated (GMP) environment
• Demonstrated level of experience and proficiency with Quality Management Systems (QMS, LIMS, EMS, FMS) is required
• Experience with document control, leading deviation investigations, leading CAPA, and leading change control
• Understanding of cGMP requirements and applicable regulatory expectations (FDA, EMA, etc.)
• Strong knowledge of root cause analysis and quality risk management principles (ICH Q9)
• Must have strong communication and cross-functional collaboration skills
• Demonstrated proficiency in Microsoft Office software (Word, Excel, PowerPoint, Outlook)
• Ability to analyze and trend data to support quality system improvements

Qualifications

This position does not have supervisory responsibilities.

Skills

• Strong knowledge of Quality Management Systems (QMS, LIMS, EMS, FMS)
• Experience with document control, leading deviation investigations, leading CAPA, and leading change control
• Understanding of cGMP requirements and applicable regulatory expectations (FDA, EMA, etc.)
• Strong knowledge of root cause analysis and quality risk management principles (ICH Q9)
• Proficiency in Microsoft Office software (Word, Excel, PowerPoint, Outlook)
• Ability to analyze and trend data to support quality system improvements

Benefits

Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.

Pay

Details about pay are not specified in the job posting.

Schedule

Details about the schedule are not specified in the job posting.