Quality Systems Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the implementation, validation, and lifecycle management of GxP computerized systems, such as eQMS and associated quality platforms.

• Collaborate across departments with IT and system owners to guarantee that systems are configured, maintained, and controlled in accordance with internal procedures and regulatory requirements (e.g., 21 CFR Part 11, Annex 11).

• Offer system-related assistance to business units, which includes troubleshooting, user support, and initiatives for continuous improvement.

• Ensure the application of data integrity principles (ALCOA+) within quality systems and support them throughout system workflows.

• Engage in system upgrades, modifications, and integrations, making sure that proper change control, validation, and risk assessment procedures are carried out.

⛳️ Requirements

• A BS/BA degree in life sciences or a related field is required.

• A minimum of 2 to 5 years of experience in a quality assurance or quality control role within a regulated (GMP) environment.

• Proven experience and proficiency with Quality Management Systems (QMS, LIMS, EMS, FMS).

• Familiarity with document control, leading deviation investigations, overseeing CAPA, and managing change control processes.

• Strong understanding of root cause analysis and quality risk management principles (ICH Q9).

• Excellent communication and cross-functional collaboration skills are essential.

• Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development