Quality Specialist Jobs

About The Position

Requirements

• Knowledge of GMP, FDA, and EMA regulations for clinical drug manufacturing.
• Knowledge of change control procedures, CAPA programs, investigations, root cause analysis, and good documentation practices.
• Demonstrated ability to collaborate and work in cross-functional teams.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time-management skills and a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks.
• Proficiency with Microsoft Office Suite or related software.
• Ability to communicate effectively and maintain productive relationships with coworkers, clients, and other external contacts.
• At least 3 years of GMP manufacturing or QA experience.
• Authorization to work for an employer in the United States; visa sponsorship or transfer is not available.
• Consistent and predictable in-person attendance.
• Ability to sit or stand for prolonged periods and work on a computer.
• Ability to lift up to 15 pounds at times.

Nice To Haves

• Bachelor’s degree in a scientific discipline preferred.

Responsibilities

• Implement and continuously improve the company’s quality systems.
• Author, review, and approve SOPs and associated documents.
• Review and approve master batch records.
• Review and release raw materials and products.
• Oversee, review, and approve investigations, CAPA, and change controls.
• Contribute to a culture of quality ownership, compliance, and continuous improvement.
• Communicate quality-related information to the internal team with guidance and recommendations.
• Support internal audits, client audits, and regulatory inspections as needed.
• Perform other duties as assigned.

Benefits

• More than four weeks of paid time off accrued annually.
• Employer contributions to a retirement account begin after 90 days; employee matching and a vesting period are not required.
• Various health plans with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.