Job Description

Quality Assurance Manager

We are seeking a highly motivated and experienced Quality Manager and Quality Engineer to lead our quality team in ensuring that all pharmaceutical products meet the highest standards of safety, efficacy, and quality. This individual will oversee the development, implementation, and continuous improvement of quality management systems, compliance with regulatory requirements, and coordination of internal audits. The ideal candidate will have a strong background in pharmaceutical manufacturing, quality control, and regulatory compliance.

QUALIFICATIONS

Education : Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related scientific/technical field. Advanced degree (MS, Ph.D.) preferred.

Experience : Minimum of 6 years of experience in pharmaceutical quality, with at least 2 years in a managerial or supervisory role.

Certifications : Relevant certifications (e.g., ASQ Certified Quality Manager, Six Sigma) are a plus.

Knowledge: Deep understanding of GMP and FDA regulations pharmaceutical regulations.

• Skills: Strong leadership, analytical, and problem-solving skills. Excellent communication, organizational, and project management abilities.

2) Quality Engineer

Qualification

Education and/or Experience

• Bachelor’s degree in Engineering, Manufacturing, Mathematics or Business. In lieu of a degree, relevant years of work experience may suffice.
• 0-3 years’ experience working within quality engineering systems.
• Experience working with, or knowledge of, business management systems particularly ISO 13485 preferred, and FDA Title 21 Part 820, QSR.
• ASQ Quality Engineer Certified within one (1) year as requested.
• Experience in or knowledge of SPC and Statistical Analysis.
• Computer skills in MS-Office and Data Analysis Software to calculate statistics (such as Excel, Mini-Tab, etc.).
• Self-Motivated analytical data driven decision maker with strong leadership skills.
• Strong commitment to quality and customer service.
• Demonstrated problem solving skills required
• Leadership Ability

Benefits:

We’re proud to offer a comprehensive benefits package, including:

• Medical Insurance – PPO & HMO plans
• Dental and Vision Coverage
• Flexible Spending Account (FSA)
• Life Insurance Options
• Short-Term and Long-Term Disability (STD/LTD)
• 401(k) Retirement Plan

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