8,523 Pharmaceutical Quality jobs in the United States

Pharmaceutical Quality Control Analyst

27511 Raleigh, North Carolina $70000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical company dedicated to advancing healthcare, is seeking a meticulous and detail-oriented Pharmaceutical Quality Control Analyst for their facility in Raleigh, North Carolina, US . This critical role ensures the quality, safety, and efficacy of pharmaceutical products by performing rigorous analytical testing and adhering to strict regulatory guidelines. The ideal candidate will possess a strong background in analytical chemistry, experience with pharmaceutical quality control procedures, and a thorough understanding of Good Manufacturing Practices (GMP). Responsibilities include conducting various laboratory tests on raw materials, in-process samples, and finished products using techniques such as HPLC, GC, UV-Vis spectroscopy, and titration. You will be responsible for preparing reagents, maintaining laboratory equipment, documenting all testing procedures and results accurately, and investigating any out-of-specification (OOS) results. Collaboration with R&D, manufacturing, and regulatory affairs departments is integral to this role. A commitment to maintaining the highest standards of quality and compliance is paramount.

Key Responsibilities:
  • Perform analytical testing on raw materials, in-process samples, and finished pharmaceutical products.
  • Utilize various analytical techniques including HPLC, GC, UV-Vis, FTIR, and wet chemistry.
  • Prepare reagents, standards, and sample solutions.
  • Operate and maintain laboratory equipment, ensuring calibration and functionality.
  • Document all testing procedures, results, and observations accurately in compliance with GMP.
  • Investigate out-of-specification (OOS) and out-of-trend (OOT) results and determine root causes.
  • Develop and validate new analytical methods as required.
  • Review and approve test data and batch records.
  • Ensure compliance with all relevant regulatory guidelines (e.g., FDA, ICH).
  • Maintain a clean and organized laboratory environment.
  • Collaborate with manufacturing, R&D, and regulatory teams to resolve quality issues.
  • Participate in internal and external audits.

Qualifications:
  • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific field.
  • Minimum of 3 years of experience in pharmaceutical quality control or analytical testing.
  • Proficiency in analytical techniques relevant to pharmaceutical analysis (HPLC, GC, spectroscopy).
  • Strong understanding of GMP, regulatory requirements, and quality assurance principles.
  • Excellent documentation and record-keeping skills.
  • Proficiency in Microsoft Office Suite and laboratory information management systems (LIMS).
  • Strong analytical and problem-solving abilities.
  • Good communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Attention to detail and commitment to accuracy.
Join a vital team contributing to the development and production of life-saving medications in Raleigh, North Carolina, US .
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Pharmaceutical Quality Control Analyst

23451 Virginia Beach, Virginia $65000 Annually WhatJobs

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Job Description

full-time
Our client, a leading pharmaceutical manufacturer, is seeking a diligent and detail-oriented Pharmaceutical Quality Control Analyst to join their team in **Virginia Beach, Virginia, US**. This role is essential in ensuring the quality and compliance of pharmaceutical products throughout the manufacturing process. You will perform a variety of analytical tests on raw materials, in-process samples, and finished products according to established protocols and regulatory guidelines (e.g., cGMP, FDA). Key responsibilities include operating and maintaining analytical instrumentation such as HPLC, GC, UV-Vis spectrophotometers, and dissolution apparatus. You will accurately document all testing results, prepare reports, and investigate any deviations or out-of-specification (OOS) results. The ideal candidate will have a strong background in chemistry, pharmaceutical sciences, or a related field, with hands-on experience in a GMP laboratory environment. Proficiency in analytical techniques and a thorough understanding of quality control principles are crucial. We are looking for an individual with excellent problem-solving skills, strong attention to detail, and the ability to work effectively both independently and as part of a team. You should be capable of managing multiple tasks and prioritizing effectively to meet production schedules and quality standards. This is an excellent opportunity to contribute to the production of safe and effective medicines and advance your career in pharmaceutical quality assurance.

Key Responsibilities:
  • Perform analytical testing on raw materials, intermediates, and finished products.
  • Operate and maintain laboratory equipment such as HPLC, GC, and spectrophotometers.
  • Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
  • Document all testing activities and results accurately in laboratory notebooks and systems.
  • Investigate and report any deviations or out-of-specification (OOS) results.
  • Prepare certificates of analysis and other quality control documentation.
  • Participate in method validation and equipment qualification activities.
  • Collaborate with production and R&D teams to resolve quality issues.
  • Ensure compliance with all relevant regulatory requirements.
  • Maintain a clean and safe laboratory environment.

Qualifications:
  • Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or a related field.
  • Experience working in a GMP pharmaceutical laboratory.
  • Proficiency with analytical instrumentation (HPLC, GC, UV-Vis, etc.).
  • Strong understanding of pharmaceutical quality control principles and regulations.
  • Excellent documentation and record-keeping skills.
  • Analytical and problem-solving abilities.
  • Detail-oriented with strong organizational skills.
  • Ability to work effectively in a team and independently.
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Pharmaceutical Quality Control Analyst

50309 Des Moines, Iowa $75000 Annually WhatJobs

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full-time
Our client is seeking a meticulous and experienced Pharmaceutical Quality Control Analyst to join their innovative team in **Des Moines, Iowa, US**. This role is central to ensuring the safety, efficacy, and quality of pharmaceutical products manufactured by the company. The analyst will perform a variety of laboratory tests and procedures on raw materials, in-process samples, and finished products using advanced analytical techniques and instrumentation. Key responsibilities include operating and maintaining analytical equipment such as HPLC, GC, UV-Vis spectrophotometers, and dissolution apparatus; preparing reagents and solutions; executing method validation protocols; meticulously documenting all experimental results and data in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP); investigating out-of-specification (OOS) results; and contributing to the continuous improvement of quality control processes. The ideal candidate will hold a Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmacy, or a closely related scientific field, with a minimum of 3 years of relevant experience in a pharmaceutical QC laboratory setting. A strong understanding of analytical chemistry principles, pharmaceutical regulations (FDA, ICH guidelines), and sterile manufacturing environments is essential. Excellent attention to detail, problem-solving skills, and the ability to work effectively both independently and as part of a team are required. This role requires strong written and verbal communication skills for report generation and cross-functional collaboration. The ability to troubleshoot analytical methods and instrumentation will be highly valued. Successful candidates will be proactive in identifying potential quality issues and implementing corrective actions.
Key Responsibilities:
  • Perform analytical testing on pharmaceutical raw materials, intermediates, and finished products.
  • Operate and maintain sophisticated laboratory instrumentation (HPLC, GC, etc.).
  • Develop and validate analytical methods according to regulatory guidelines.
  • Document all laboratory activities and results accurately and thoroughly.
  • Investigate and troubleshoot out-of-specification test results.
  • Ensure compliance with GMP, GLP, and relevant pharmaceutical regulations.
  • Prepare Certificates of Analysis (CoA) for released products.
  • Collaborate with R&D and production teams on quality-related matters.
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Pharmaceutical Quality Control Analyst

80901 Colorado Springs, Colorado $65000 Annually WhatJobs

Posted 2 days ago

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Job Description

full-time
Our client is seeking a meticulous and dedicated Pharmaceutical Quality Control Analyst to join their team in Colorado Springs, Colorado, US . In this critical role, you will perform a wide range of analytical tests on raw materials, in-process samples, and finished products to ensure they meet stringent quality standards and regulatory requirements. Your responsibilities will include operating and maintaining laboratory equipment, developing and validating analytical methods, and accurately documenting all test results and procedures. You will work closely with the Quality Assurance department to investigate deviations, out-of-specification (OOS) results, and ensure compliance with Good Manufacturing Practices (GMP). A strong foundation in analytical chemistry, spectroscopy, chromatography, and other relevant laboratory techniques is essential. The ideal candidate is detail-oriented, highly organized, and committed to maintaining the highest quality standards in pharmaceutical manufacturing. Responsibilities include:
  • Perform quantitative and qualitative analysis of pharmaceutical products using various laboratory techniques (e.g., HPLC, GC, UV-Vis, FTIR).
  • Conduct tests on raw materials, intermediates, and finished goods according to approved specifications and test methods.
  • Operate, calibrate, and maintain laboratory instrumentation.
  • Document all experimental procedures, results, and observations in compliance with GMP and company SOPs.
  • Prepare reagents, solutions, and samples for testing.
  • Assist in the investigation of out-of-specification (OOS) results and deviations.
  • Contribute to method validation and transfer activities.
  • Maintain laboratory cleanliness and orderliness.
  • Participate in internal and external audits.
  • Stay current with industry trends and advancements in analytical techniques.
Qualifications:
  • Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or a related science field.
  • Minimum of 3 years of experience in a pharmaceutical QC laboratory setting.
  • Hands-on experience with analytical instrumentation such as HPLC, GC, and dissolution testers.
  • Knowledge of USP, EP, and other relevant pharmacopeial methods.
  • Familiarity with GMP, ICH, and FDA regulations.
  • Strong understanding of analytical chemistry principles.
  • Excellent attention to detail and accuracy.
  • Proficient in laboratory notebook keeping and data reporting.
  • Ability to work independently and as part of a team.
  • Strong problem-solving skills.
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Pharmaceutical Quality Control Analyst

83701 Emmett, Idaho $75000 Annually WhatJobs

Posted 3 days ago

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full-time
Our client is seeking a highly motivated Pharmaceutical Quality Control Analyst to join their state-of-the-art facility in Boise, Idaho . This is a critical, on-site role focused on ensuring the quality and integrity of pharmaceutical products throughout the manufacturing process. You will be responsible for performing a variety of analytical tests on raw materials, in-process samples, and finished products using sophisticated laboratory equipment. Key responsibilities include adhering strictly to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), conducting sample preparation, executing analytical methods such as HPLC, GC, UV-Vis, and titration, and meticulously documenting all results in compliance with regulatory standards. You will interpret test data, identify any deviations from specifications, and participate in the investigation of out-of-specification (OOS) results. Maintaining laboratory equipment, calibrating instruments, and managing laboratory inventory are also essential functions. The ideal candidate possesses a strong scientific background, excellent attention to detail, and a commitment to upholding the highest quality standards in a pharmaceutical manufacturing environment. This role offers an excellent opportunity to contribute to the development and production of life-saving medications.

Key Responsibilities:
  • Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products.
  • Utilize various analytical techniques including HPLC, GC, spectroscopy (UV-Vis, IR), and wet chemistry.
  • Prepare samples for analysis according to established protocols.
  • Accurately record and document all test results in compliance with GMP/GLP.
  • Identify and report any out-of-specification (OOS) or non-conforming results.
  • Participate in OOS investigations and root cause analysis.
  • Calibrate, maintain, and troubleshoot laboratory equipment.
  • Manage laboratory supplies and inventory.
  • Ensure adherence to all safety procedures and regulatory guidelines.
  • Review and revise standard operating procedures (SOPs) as needed.

Qualifications:
  • Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or a related life science field.
  • Minimum of 2-4 years of experience in pharmaceutical quality control or analytical testing.
  • Hands-on experience with HPLC and GC is required.
  • Strong understanding of GMP, GLP, and ICH guidelines.
  • Excellent analytical and problem-solving skills.
  • Meticulous attention to detail and strong documentation skills.
  • Proficiency in Microsoft Office Suite.
  • Ability to work effectively in a team-oriented laboratory environment.
  • Knowledge of other analytical techniques (e.g., dissolution, Karl Fischer) is a plus.
  • Must be able to work on-site in Boise, Idaho.
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Pharmaceutical Quality Engineer

08873 Franklin Township, New Jersey Kelly Services

Posted 11 days ago

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**Quality Validations Engineer- Somerset NJ**
**Summary of Essential Functions:**
The Quality Applications Engineer is tasked with supporting, maintaining, and optimizing digital quality systems and applications across the organization. This role ensures that all quality-related software tools are effectively implemented and aligned with regulatory requirements and business needs. The engineer collaborates with cross-functional teams to drive continuous improvement and system integration.
**Specific Duties, Activities, and Responsibilities:**
+ Serve as the technical lead for quality system applications including QMS, LIMS, and document control platforms.
+ Configure, maintain, and troubleshoot quality software tools to ensure optimal performance and compliance.
+ Collaborate with IT and Quality teams to implement system upgrades, integrations, and enhancements.
+ Develop and maintain user documentation, training materials, and SOPs related to quality applications.
+ Support internal and external audits by providing system access, data retrieval, and documentation.
+ Analyze system data to identify trends and opportunities for process improvement.
+ Ensure systems meet GMP, GLP, and other applicable regulatory standards.
+ Provide end-user support and training across departments.
+ Participate in validation activities for new systems and upgrades.
+ Manage change control processes related to quality applications.
+ Comply with Health, Safety, and Environmental responsibilities for the position.
+ Adhere to company standards for data integrity and regulatory compliance.
**Education and Experience:**
+ Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
+ 3+ years of experience in quality systems or applications support within a regulated industry (pharmaceutical, biotech, or medical device).
+ Experience with system validation and compliance documentation (IQ/OQ/PQ).
**Knowledge/Skills:**
+ Strong understanding of GMP/GLP regulations and quality system requirements.
+ Hands-on experience with QMS platforms (e.g., MasterControl), LIMS, and ERP systems.
+ Familiarity with FDA 21 CFR Part 11 compliance and data integrity principles.
+ Proficiency in SQL, data visualization tools, and reporting platforms.
+ Excellent problem-solving, communication, and project management skills.
+ Ability to translate business needs into technical solutions.
**Work Environment/Safety Conditions:**
+ Office-based role with occasional access to laboratory or manufacturing environments.
+ Must adhere to all company safety protocols and procedures.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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Pharmaceutical - Quality Assurance Analyst

Premium Job
Remote $24 - $65 per hour Appraisals Phoenix And Estates LLC

Posted 2 days ago

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Full time Permanent

As a global leader in ever expanding power and energy industry, we are looking for a skilled and motivated Software Developer to join our growing team. This role is focused on creating solutions that drive efficiency and innovation in our engineering and design processes.

Role Overview

The QA Analyst will play a critical role in ensuring software quality and business alignment by developing, implementing, and executing comprehensive test strategies—with an emphasis on User Acceptance Testing (UAT) and a variety of test platforms. The ideal candidate will thrive in Agile environments, collaborate across teams, and support the entire software development lifecycle through to production release.

Responsibilities
• Test Planning & Strategy - Develop, review, and implement detailed test plans and strategies mapped to business requirements, user stories, and acceptance criteria. - Design UAT processes in close collaboration with business stakeholders, ensuring user needs and business goals are fully validated before software release.

• UAT Management - Coordinate with business users and product owners to define, organize, and execute UAT cycles. - Drive creation and maintenance of UAT test cases, identifying necessary test data, and ensuring alignment with acceptance criteria. - Facilitate UAT sign-off, capture user feedback, and ensure all defects or issues are logged, tracked, and resolved before production deployment.

• Test Execution & Automation - Execute functional, integration, regression, Performance, and exploratory testing across multiple test environments (Dev, QA, Stage, UAT). - Utilize relevant test platforms, such as Jira, Azure DevOps, and HP Quality Center, for managing test cases, defect tracking, and traceability. - Prioritize and automate high-value test cases, working with CI/CD pipelines where appropriate.

• Database Testing: Perform backend testing using SQL and Oracle to validate data accuracy, integrity, and consistency across systems. Write and execute complex queries to verify business logic, data transformations, and stored procedures. Validate data migration and ensure referential integrity across environments.

• Defect Management - Identify, log, track, and retest defects found during all phases of testing. - Prepare and distribute test summary reports, including defect logs and closure status.

• Collaboration & Continuous Improvement - Partner with product owners, business analysts, developers, and release managers, ensuring clear user story and acceptance criteria definition. - Participate in Agile ceremonies—sprint planning, stand-ups, demos, retrospectives—offering feedback and suggesting quality improvements. - Support root cause analysis and postmortem for defects found in production environments.

This position offers the flexibility of a hybrid schedule

Qualifications
• 3+ years proven experience in software QA, including hands-on experience developing and executing UAT cycles and working with various test platforms.

• Solid understanding of Agile methodologies (Scrum, Kanban) and test management tools (e.g., Jira, Azure DevOps, HP Quality Center).

• Proficiency in SQL for validating data

• Experience in Automation tools –Selenium, Test Sigma, Test Rigor, TestIM, QTP, Postman, SOAPUI, JMeter, Load Runner

• Comfortable writing clear, traceable test cases, mapping them to user stories, and updating them throughout the project lifecycle.

• Demonstrated ability to coordinate and facilitate UAT with internal users and business stakeholders, ensuring thorough documentation and sign-off.

• Familiarity with test automation principles and CI/CD processes. Ability to write/Develop scripts to automate test cases and build test frameworks.

• Experience with defect lifecycle management, from logging through resolution, using modern test and project management platforms.

• Strong communication, organizational, and interpersonal skills—capable of working effectively in cross-functional Agile teams.

Preferred Qualifications

• Bachelor’s degree in Computer Science, Information Systems, or a related field.

• Experience with both manual and automated testing approaches across web and cloud-based applications.

• Exposure to multiple test environments (Dev, QA, Stage, UAT, Prod) and their configuration requirements.

• Certifications such as ISTQB, CSTE, or Agile certifications are a plus.

Why Join Us?

• Work in an established company that values innovation and growth.

• Engage with a collaborative team that is dedicated to making a meaningful impact in the energy sector.

• Gain exposure to cutting-edge projects and contribute to data-driven decision-making processes.

Company Details

With over 32 years of experience in the Phoenix market, Appraisals Phoenix Estates LLC specializes in appraisals, estate auctions, and real estate services. The company provides compassionate and professional support for clients facing situations such as illness, death, divorce, or downsizing. They also offer private brokering for high-value items and estate buyouts for quick asset conversion. Their extensive knowledge and community ties enable them to deliver trusted services tailored to the needs of their clients.
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About the latest Pharmaceutical quality Jobs in United States !

Pharmaceutical Quality Assurance Manager

85001 Whispering Pines, Arizona $125000 Annually WhatJobs

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full-time
Our client, a prominent pharmaceutical company, is looking for a meticulous and experienced Pharmaceutical Quality Assurance Manager to oversee quality operations at their facility in **Phoenix, Arizona, US**. This hybrid role is crucial for ensuring that all products meet rigorous quality standards and regulatory requirements throughout the manufacturing process. The ideal candidate will have a comprehensive understanding of GMP (Good Manufacturing Practices), FDA regulations, and other relevant industry guidelines. You will lead a team of QA specialists, implementing and maintaining robust quality management systems. Key responsibilities include developing and executing QA strategies, conducting internal audits and inspections, and managing external regulatory audits. You will also be responsible for reviewing and approving batch records, validation protocols, and other critical quality documentation. Identifying and addressing deviations, implementing CAPAs (Corrective and Preventive Actions), and driving continuous improvement initiatives within the quality framework are essential. The ability to analyze quality data, identify trends, and implement effective solutions to enhance product quality and compliance is paramount. Strong leadership, problem-solving, and communication skills are required to collaborate effectively with cross-functional teams, including manufacturing, R&D, and regulatory affairs. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required. A Master's degree or advanced certification in a relevant field is preferred. A minimum of 7-10 years of experience in pharmaceutical quality assurance or quality control is mandatory. Previous experience in a management or supervisory role within the pharmaceutical industry is essential. Thorough knowledge of pharmaceutical manufacturing processes and quality systems is expected. This role offers a significant opportunity to influence product quality and ensure patient safety.
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Pharmaceutical Quality Assurance Manager

77001 Houston, Texas $125000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical manufacturer in **Houston, Texas, US**, is seeking a highly qualified and experienced Pharmaceutical Quality Assurance Manager to oversee and ensure compliance with all relevant regulatory standards and internal quality policies. This critical role will be responsible for maintaining the integrity and quality of our pharmaceutical products throughout the manufacturing lifecycle. The ideal candidate will possess a strong background in pharmaceutical quality systems, regulatory affairs, and GMP compliance, along with exceptional leadership and analytical skills. Responsibilities include developing, implementing, and maintaining the company's Quality Management System (QMS); overseeing all QA activities, including batch record review, deviation management, CAPA implementation, change control, and internal/external audits; ensuring compliance with FDA regulations (21 CFR Parts 210/211), ICH guidelines, and other applicable international standards; managing and mentoring the QA team; conducting risk assessments and implementing mitigation strategies; reviewing and approving validation protocols and reports; and collaborating with other departments, such as manufacturing, R&D, and regulatory affairs, to ensure consistent quality. You will also be responsible for driving continuous improvement initiatives within the quality function and representing the company during regulatory inspections. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline is required. A minimum of 7 years of experience in pharmaceutical Quality Assurance, with at least 3 years in a management or supervisory role, is essential. Strong knowledge of GMP, QSR, and global regulatory requirements is mandatory. Excellent communication, leadership, and problem-solving skills are critical. Join our innovative team in **Houston, Texas, US**, and play a vital role in bringing high-quality medicines to patients.
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Pharmaceutical Quality Assurance Specialist

45202 Cincinnati, Ohio $85000 Annually WhatJobs

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full-time
Our client is looking for a meticulous and dedicated Pharmaceutical Quality Assurance Specialist to join their quality control department in Cincinnati, Ohio, US . This vital role will ensure that all pharmaceutical products manufactured meet stringent quality standards and comply with regulatory requirements. The Pharmaceutical Quality Assurance Specialist will be responsible for developing, implementing, and maintaining quality assurance systems and procedures throughout the product lifecycle. This includes reviewing and approving batch records, deviations, change controls, and validation protocols. You will conduct internal audits, participate in external audits, and work closely with manufacturing, R&D, and regulatory affairs teams to address quality issues and implement corrective and preventive actions (CAPAs). Key responsibilities also involve performing equipment calibration checks, monitoring environmental conditions, and ensuring that all laboratory testing is conducted according to approved methods. The ideal candidate possesses a strong understanding of Good Manufacturing Practices (GMP), FDA regulations, and quality management systems within the pharmaceutical industry. Excellent analytical skills, a keen eye for detail, strong documentation practices, and effective communication abilities are essential. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field, along with a minimum of 3 years of experience in pharmaceutical quality assurance, is required. Experience with OOS investigations and batch release processes is a significant advantage. If you are committed to upholding the highest standards in pharmaceutical quality, we encourage you to apply.
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