Specialist Quality Assurance

Payrate: $34.00 - $36.00/hr.

We are seeking a Quality Specialist to support Company’s digital quality transformation by leading validation testing, driving change management, and managing cross-functional projects across our digital Quality platforms. This role ensures that enhancements to our digital quality systems such as batch release, quality workflows, and integrated data solutions are compliant, reliable, and successfully adopted by global users.

• Lead validation activities for digital quality system updates, including test planning, execution, documentation, and issue resolution.
• Drive change management to support new system capabilities, user adoption, communications, and training.
• Manage multiple digital quality projects involving system enhancements, process improvements, and cross-functional coordination.
• Ensure digital workflows and integrations supporting material and product release meet GxP requirements.
• Collaborate with internal partners and external vendors to ensure timely, compliant, and high-quality delivery.

• Strong GxP background with direct experience in material and product release.
• Hands‑on experience with digital quality systems (e.g., eQMS, complaint systems, digital batch release, quality data integrations).
• Proven capabilities in validation testing, change management, and project leadership.
• Excellent communication skills (English & Spanish preferred) and ability to work effectively in a matrixed, cross‑functional environment.
• Exceptional attention to detail, analytical mindset, and ability to manage competing priorities.

• 5+ years of biopharmaceutical experience in Quality, Validation, Manufacturing, Regulatory, or related areas.
• Knowledge of GMP regulations, digital quality systems, and modern quality technologies.

The typical base pay for this role across the U.S. is: $34.00 - $36.00/hr non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience.

Full‑time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus.

Sick leave and mobile phone reimbursement provided based on state or local law.