6,313 Pharmaceutical Qa jobs in the United States

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.

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.

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.

Our client, a prominent player in the pharmaceutical industry, is seeking a detail-oriented Pharmaceutical Quality Assurance Specialist to join their team in Omaha, Nebraska, US . This role is crucial for maintaining the highest standards of quality and compliance throughout the pharmaceutical product lifecycle, ensuring adherence to regulatory requirements and internal quality systems. The ideal candidate will have a strong understanding of GMP, quality control, and regulatory affairs within the pharmaceutical sector.

Key Responsibilities:

• Reviewing and approving batch records, validation documentation, and quality control data.
• Participating in internal and external audits and inspections, ensuring readiness and compliance.
• Investigating deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Developing and updating quality procedures, work instructions, and training materials.
• Monitoring and ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
• Conducting risk assessments related to product quality and manufacturing processes.
• Managing change control processes, ensuring proper evaluation and implementation of changes.
• Supporting regulatory submissions by providing necessary quality documentation.
• Collaborating with cross-functional teams, including manufacturing, R&D, and supply chain, to resolve quality issues.
• Performing vendor qualification and audits to ensure the quality of supplied materials.
• Releasing finished products after thorough review of all quality attributes.
• Staying informed about evolving regulatory requirements and industry best practices.
• Leading quality improvement initiatives and contributing to the overall quality culture.
• Ensuring data integrity and accuracy in all quality-related documentation.

A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline is required. A minimum of 5 years of experience in pharmaceutical quality assurance or quality control is essential. Strong knowledge of GMP, ICH guidelines, and regulatory requirements for drug manufacturing is mandatory. Experience with electronic quality management systems (eQMS) is a plus. Excellent analytical, problem-solving, and communication skills are required. The ability to manage multiple tasks and prioritize effectively is crucial. Join our client in upholding the highest standards of pharmaceutical quality.

A prestigious pharmaceutical company is looking for a dedicated Pharmaceutical Quality Assurance Manager to oversee quality control and compliance initiatives in Phoenix, Arizona, US . This leadership role is crucial for ensuring that all products meet stringent regulatory standards set by agencies such as the FDA. The successful candidate will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS), which includes standard operating procedures (SOPs), batch record reviews, deviation investigations, and CAPA (Corrective and Preventive Actions) management. You will lead and mentor a team of QA specialists, fostering a culture of quality excellence throughout the organization. Responsibilities include conducting internal audits, managing external audits from regulatory bodies and partners, and ensuring all documentation is accurate, complete, and compliant. A deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmaceutical regulations is paramount. The ideal candidate will have exceptional attention to detail, strong decision-making abilities, and excellent interpersonal and communication skills to effectively collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline is required, with a Master's degree or advanced certifications being a significant plus. A minimum of 7 years of experience in pharmaceutical quality assurance, with at least 3 years in a management capacity, is essential for this role. If you are passionate about ensuring patient safety and product integrity, this is an exceptional opportunity to advance your career.

Our client , a prominent pharmaceutical company, is looking for a meticulous and detail-oriented Pharmaceutical Quality Assurance Specialist to join their team at their St. Louis facility. This is an on-site role, critical for ensuring the integrity and compliance of our pharmaceutical products throughout the manufacturing process. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS) in accordance with regulatory requirements such as FDA (cGMP) and ICH guidelines. Your duties will include conducting internal audits, reviewing batch records, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPA). You will also be involved in validating processes, equipment, and analytical methods, and ensuring that all activities meet the highest standards of quality and safety. The ideal candidate will have a strong understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control principles. Excellent analytical and problem-solving skills are essential, along with meticulous attention to detail. You must be proficient in documentation, data review, and risk assessment. A Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or a related life science field is required. At least 4 years of experience in quality assurance or quality control within the pharmaceutical or biotechnology industry is necessary. Strong knowledge of Good Manufacturing Practices (GMP) and regulatory submission processes is crucial. You will be expected to work collaboratively with various departments, including R&D, manufacturing, and regulatory affairs, to ensure continuous improvement and compliance. Effective communication and interpersonal skills are vital for training personnel and presenting quality-related information. This role requires a commitment to upholding the highest standards in a demanding, hands-on environment.

Our client is seeking a meticulous and detail-oriented Pharmaceutical Quality Assurance Specialist to join their esteemed team in Atlanta, Georgia, US . This role is critical in ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining quality management systems, conducting internal audits, and managing documentation to ensure compliance with cGMP (current Good Manufacturing Practices). Key responsibilities include reviewing batch records, investigating deviations and out-of-specification results, and collaborating with production and laboratory teams to resolve quality issues. The ideal candidate will have a solid understanding of pharmaceutical manufacturing processes, regulatory affairs, and a commitment to upholding the highest standards of quality and safety.
Responsibilities:

• Ensure compliance with cGMP, FDA, and other relevant regulatory guidelines.
• Develop, implement, and maintain the Quality Management System (QMS).
• Review and approve batch manufacturing records, analytical data, and validation reports.
• Conduct internal audits and participate in external regulatory inspections.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints.
• Implement corrective and preventive actions (CAPAs) to address quality issues.
• Manage change control processes and assess the impact of changes on product quality.
• Perform supplier qualification and ongoing monitoring of contract manufacturers.
• Collaborate with cross-functional teams to resolve quality-related issues.
• Contribute to the continuous improvement of quality processes and systems.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree is a plus.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or biotech industry.
• In-depth knowledge of cGMP regulations and quality systems.
• Experience with audit processes, CAPA systems, and change control.
• Strong analytical and problem-solving skills with excellent attention to detail.
• Proficiency in documentation control and batch record review.
• Excellent written and verbal communication skills.
• Ability to work effectively in a collaborative, team-oriented environment.
• Familiarity with pharmaceutical manufacturing processes and analytical testing methods.
• Knowledge of ICH guidelines is highly desirable.

This position offers a great opportunity to grow your career in pharmaceutical quality assurance within a leading company.

Our client, a reputable pharmaceutical company based in Phoenix, Arizona, US , is seeking an experienced and proactive Pharmaceutical Quality Assurance Manager to lead their Quality Assurance department. This leadership position is crucial for maintaining the highest standards of product quality and regulatory compliance throughout the manufacturing and development lifecycle. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS), ensuring it aligns with current Good Manufacturing Practices (cGMP) and other relevant regulatory guidelines. Key responsibilities include overseeing quality control operations, managing audits (internal and external), reviewing and approving batch records, and investigating deviations and out-of-specification (OOS) results. You will lead and mentor a team of quality professionals, fostering a culture of continuous improvement and quality excellence. The ideal candidate will have a comprehensive understanding of pharmaceutical manufacturing processes, quality systems, and regulatory affairs. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline is required; a Master's degree or advanced degree is highly preferred. Significant experience in pharmaceutical quality assurance, with demonstrated leadership capabilities, is essential. Strong analytical, problem-solving, and decision-making skills are critical. Excellent communication and interpersonal skills are necessary to effectively collaborate with cross-functional teams and regulatory agencies. If you are a strategic thinker with a passion for ensuring product safety and efficacy, we encourage you to apply.

**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.
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