Description:
The Quality Assurance Specialist is responsible for ensuring 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.
Essential Functions:
- 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. Participates in Investigation of product complaints and assures implementation and documentation of corrective actions. 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 took to implement process improvements, enhance product quality and reduce process variance. Provides routine analysis of performance indicators (yield, NCs, Complaints, etc.). Evaluate 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.
Additional Responsibilities:
- Assists in Annual Product Review.
- Conducts audits of processes and analyze statistical data to facilitate Continuous Improvement.
- Acts as a quality representative for material review board (MRB).
Education:
- Bachelors Degree (BA/BS) Related Field - Required
- Vocational / Technical CQE Certification, Quality Assurance or related field - Preferred
Experience:
- 5 years or more in Related field
Specialized Knowledge:
- 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
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. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. 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.
Skills Required
- Bachelor's Degree (BA/BS) in a related field
- 5 years or more in a related field
- Vocational / Technical CQE Certification or Quality Assurance related certification
- FDA inspection experience
- Knowledge of 21 CFR Parts 210, 211 and Part 820
- Experience performing IQ, OQ, PQ and equipment qualification activities
- Experience with Six Sigma, SPC, PFMEA, Gage R&R, Cpk and process capability studies
- Experience conducting root cause analysis, complaint investigations, and corrective actions
Amneal Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Amneal Pharmaceuticals and has not been reviewed or approved by Amneal Pharmaceuticals.
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Healthcare Strength — Medical coverage is presented as comprehensive with day-one eligibility for many U.S. roles, supported by wellness resources and transparency around plan information.
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Affordable Benefits — Employer contributions toward health coverage are described as generous, including periods where cost increases were absorbed and future employee contributions kept below broader trends.
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Retirement Support — A 401(k) plan with a company match and strong participation is positioned as a core element of the Total Rewards package.
Amneal Pharmaceuticals Insights
What We Do
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
