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Pharmaceutical Quality Assurance Inspector Jobs in Rochester, NY

QA Analyst

Macedon, NY ยท On-site

Performs Pre-Operational Inspections * Performs perfect package checks on applicable productions ... or pharmaceutical manufacturing is strongly preferred. * HAACP training strongly preferred.

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve ... Inspections. โ€ข Ensures deviations, change controls, etc. are technically sound from a quality ...

The Quality Assurance Inspector performs inspection of optical components, metal/manufactured parts, subassemblies/assemblies, products and/or materials for quality and conformance to designed ...

Conduct Quality Assurance audits and routine checks, tests, gauging and instrument inspections of materials, work in process and finished product. Assure company and product standards are maintained ...

Conduct Quality Assurance audits and routine checks, tests, gauging and instrument inspections of materials, work in process and finished product. Assure company and product standards are maintained ...

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve ... Document inspection activities and outcomes in TrackWise in accordance with required timelines.

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Pharmaceutical Quality Assurance Inspector information

See Rochester, NY salary details

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How much do pharmaceutical quality assurance inspector jobs pay per hour?

As of Aug 30, 2026, the average hourly pay for pharmaceutical quality assurance inspector in Rochester, NY is $22.53, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $25.38 per hour, depending on experience, location, and employer.

What does a pharmaceutical quality assurance inspector do?

A Pharmaceutical Quality Assurance Inspector is responsible for ensuring that pharmaceutical products are manufactured in compliance with regulatory standards and company quality policies. They conduct inspections, audits, and tests throughout the production process to identify any deviations or defects. Their role helps ensure that medicines are safe, effective, and meet strict quality requirements before reaching consumers. Inspectors also document findings and recommend corrective actions when necessary. This position is critical for maintaining public health and upholding industry regulations.

What are the key skills and qualifications needed to thrive as a pharmaceutical quality assurance inspector?

To thrive as a Pharmaceutical Quality Assurance Inspector, you need a solid understanding of GMP regulations, quality control processes, and a relevant degree in pharmacy, chemistry, or a related field. Familiarity with laboratory equipment, quality management systems (QMS), and certifications like ISO 9001 or Six Sigma are commonly required. Strong attention to detail, analytical thinking, and effective communication help inspectors identify issues and collaborate with production teams. These skills ensure that pharmaceutical products consistently meet safety and regulatory standards, protecting both consumers and company reputation.

What are some common challenges faced by pharmaceutical quality assurance inspectors, and how can they be addressed?

Pharmaceutical Quality Assurance Inspectors often face challenges such as staying current with evolving regulatory standards, managing documentation accuracy, and ensuring adherence to Good Manufacturing Practices (GMP) across multiple teams. These challenges can be addressed by participating in regular training sessions, fostering open communication between production and QA teams, and implementing robust documentation systems. Inspectors who proactively collaborate with colleagues and stay informed about industry updates are better equipped to maintain compliance and prevent quality issues.

What is the difference between Pharmaceutical Quality Assurance Inspector vs Pharmaceutical Quality Control Analyst?

AspectPharmaceutical Quality Assurance InspectorPharmaceutical Quality Control Analyst
Primary FocusEnsuring compliance with quality standards and procedures during manufacturingTesting and analyzing raw materials, in-process, and finished products for quality
Work EnvironmentManufacturing facilities, inspection stationsLaboratories, testing labs
CertificationsGMP training, quality assurance certificationsLaboratory certifications, analytical testing training
Employer & Industry UsagePharmaceutical manufacturing companies, biotech firmsQuality control labs, pharmaceutical companies

While both roles focus on quality in pharmaceuticals, the Pharmaceutical Quality Assurance Inspector primarily ensures compliance during production, whereas the Pharmaceutical Quality Control Analyst conducts detailed testing and analysis of products. Both roles are essential for maintaining product quality and safety in the pharmaceutical industry.

How to become a pharmaceutical quality assurance inspector?

To become a pharmaceutical quality assurance inspector, candidates typically need a bachelor's degree in pharmacy, chemistry, biology, or a related field. Relevant experience in pharmaceutical manufacturing or quality control, along with knowledge of Good Manufacturing Practices (GMP) and regulatory standards, is often required. Certifications such as Certified Quality Auditor (CQA) can enhance job prospects in this role.

Is a pharmaceutical quality assurance inspector a good career?

A pharmaceutical quality assurance inspector plays a vital role in ensuring the safety and compliance of pharmaceutical products by inspecting manufacturing processes and documentation. The role typically requires attention to detail, knowledge of Good Manufacturing Practices (GMP), and relevant certifications, offering stable employment opportunities in the healthcare industry. It can be a rewarding career for those interested in quality control and regulatory compliance.

Is pharmaceutical quality assurance inspection a good career?

Pharmaceutical quality assurance inspection is a stable and important role within the pharmaceutical industry, focusing on ensuring compliance with regulatory standards and product quality. It often requires attention to detail, knowledge of Good Manufacturing Practices (GMP), and relevant certifications, making it a valuable career for those interested in quality control and regulatory compliance.

What are popular job titles related to Pharmaceutical Quality Assurance Inspector jobs in Rochester, NY?

For Pharmaceutical Quality Assurance Inspector jobs in Rochester, NY, the most frequently searched job titles are:

What job categories do people searching Pharmaceutical Quality Assurance Inspector jobs in Rochester, NY look for?

The top searched job categories for Pharmaceutical Quality Assurance Inspector jobs in Rochester, NY are:

What cities near Rochester, NY are hiring for Pharmaceutical Quality Assurance Inspector jobs?

Cities near Rochester, NY with the most Pharmaceutical Quality Assurance Inspector job openings:

Quality Assurance Engineer

Stark Pharma Solutions Inc

Rochester, NY โ€ข On-site

Contractor

Re-posted 15 hours ago


Job description

Hi,

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Quality Assurance Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

Job Title: Quality Assurance Engineer
Location: New York
Duration: Long Term

Position Overview

We are seeking an experienced Quality Assurance Engineer to support quality assurance activities within a pharmaceutical, biotechnology, or medical device manufacturing environment. This role will focus on ensuring product quality, regulatory compliance, and continuous process improvement by supporting quality systems, inspections, audits, documentation, and CAPA activities. The ideal candidate will have strong knowledge of FDA regulations, GMP, ISO standards, and quality management systems while collaborating with cross-functional teams to maintain the highest quality standards.

Key Responsibilities

• Perform quality inspections, manufacturing audits, and process reviews to ensure compliance with quality standards.

• Review batch records, device history records, and quality documentation for accuracy and regulatory compliance.

• Ensure compliance with FDA regulations, GMP, ISO 13485, and company quality management systems.

• Investigate quality issues, non-conformances, deviations, and customer complaints, and support CAPA activities.

• Participate in internal audits, supplier audits, and regulatory inspections while ensuring audit readiness.

• Collaborate with Manufacturing, Engineering, Regulatory Affairs, Validation, and Quality Control teams to improve product quality and manufacturing processes.

• Develop, review, and maintain quality procedures, SOPs, work instructions, and technical documentation.

• Support risk assessments, root cause analysis, change control, and continuous improvement initiatives.

• Monitor quality metrics and analyze trends to identify opportunities for process improvement and operational excellence.

• Ensure compliance with company quality policies and applicable regulatory requirements throughout the product lifecycle.

Required Qualifications

• Bachelor's Degree in Engineering, Biotechnology, Life Sciences, Chemistry, Biology, or a related scientific discipline.

• 2–5 years of Quality Assurance experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.

• Strong knowledge of FDA regulations, GMP, ISO 13485, CAPA, Quality Management Systems (QMS), and regulatory compliance requirements.

• Experience performing quality inspections, manufacturing audits, documentation review, and quality investigations.

• Hands-on experience with deviations, non-conformances, root cause analysis, CAPA, and change control processes.

• Familiarity with quality documentation, batch record review, SOP development, and document control systems.

• Experience supporting internal audits, supplier audits, and regulatory inspections.

• Strong analytical, problem-solving, technical documentation, and organizational skills.

• Excellent communication and cross-functional collaboration skills with the ability to work effectively in a regulated environment.

• Experience working within pharmaceutical, biotechnology, or medical device manufacturing facilities is highly preferred.

• Knowledge of statistical quality tools, risk management methodologies, Lean Manufacturing, or Six Sigma is an added advantage.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/