Quality Assurance Specialist

About the role

The Quality Assurance Specialist ensures products and processes meet quality standards through validation activities, quality investigations, complaint handling, process monitoring, and continuous improvement initiatives. This role partners closely with production, engineering, suppliers, and product development teams to drive compliance, root cause analysis, process validation, and the implementation of quality systems using tools such as Six Sigma, SPC, PFMEA, and process capability studies.

Responsibilities

• Participates in the change control process and assures proposed changes are compliant to the quality system requirements.
• Performs and approves IQs, OQs and PQs of manufacturing, purchasing and test documentation to ensure fulfillment of quality requirements.
• Oversees clean room environments, including qualification and monitoring.
• Reviews inspection criteria, inspection methods and procedures based on acceptable quality standards.
• Conducts technical and statistical investigations on quality problems.
• Recommends and assists in implementing manufacturing improvements based on quality investigations.
• Evaluates customer complaints to identify failure trends.
• Conducts root-cause analysis as assigned relating to customer complaint and product returns.
• Works with product development, Tech services and production during product transfer to ensure quality deliverables (PFMEA, Control Plans, Inspection Plan, Inspection Equipment and Tooling) are in place.
• Conducts engineering studies related to Gage R&R, Cpk, SPC and Process Validation.
• Utilizes Six Sigma, SPC and other quality tools to implement process improvements, enhance product quality and reduce process variance.
• Provides routine analysis of performance indicators (yield, NCs, Complaints, etc.).
• Evaluates quality control test results for trend analysis.
• Identifies areas of systematic weakness, and leads to initiatives to implement corrective action.
• Presents this information to management, supervisors, and manufacturing operators.
• Provides technical and quality support to suppliers.
• Assists in Annual Product Review.
• Conducts audits of processes and analyzes statistical data to facilitate Continuous Improvement.
• Acts as a quality representative for material review board (MRB).

Qualifications

• Education: Bachelors Degree (BA/BS) in a related field - Required
• Vocational / Technical CQE Certification, Quality Assurance or related field - Preferred
• Experience: 5 years or more in a related field

Specialized Knowledge

• A high energy level and organizational skills.
• A certain degree of creativity and latitude is required.
• Must have FDA inspection experience.
• Engineering Equipment Qualification Activities
• 21 CFR Parts 210, 211 and Knowledge of Parts 820

Pay

The base salary for this position ranges from $85,000 to $100,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.

Benefits

This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.