Quality Assurance Consultant

Azzur Group; Boston (MA); On-site; USD 85,000 - 95,000; Full time

Job summary

Ein etabliertes Unternehmen in der pharmazeutischen Branche sucht einen detailorientierten Quality Assurance Specialist. Diese spannende Position erfordert die Überwachung von Qualitätssicherungsaktivitäten, einschließlich der Überprüfung von Validierungsdokumenten, Änderungsmanagement und Audits, um die Einhaltung von GMP und regulatorischen Standards zu gewährleisten. Der ideale Kandidat bringt umfangreiche Erfahrung in der Qualitätssicherung mit und hat ein tiefes Verständnis für Validierungsprozesse und regulatorische Anforderungen. Sie werden in einem dynamischen Umfeld arbeiten, das Innovation und kontinuierliche Verbesserung fördert, und haben die Möglichkeit, einen bedeutenden Einfluss auf die Produktqualität und Sicherheit zu nehmen.

Benefits

Gesundheitsversorgung (medizinisch, zahnärztlich, sehfähig)

Rentenplan (401k)

Lebensversicherung (Basis, freiwillig & AD&D)

Bezahlte Freizeit (Urlaub, Krankheit & Feiertage)

Qualifications

• 3-5 Jahre Erfahrung in der Qualitätssicherung in der pharmazeutischen Industrie.
• Erfahrung mit regulatorischen Inspektionen (FDA, EMA) und internen Audits.
• Starke Kenntnisse der GMP und ISO-Standards.

Responsibilities

• Überprüfung und Genehmigung von Validierungsprotokollen und Änderungsanträgen.
• Leitung von Untersuchungen zu Abweichungen und Nichtkonformitäten.
• Durchführung interner Audits zur Sicherstellung der Compliance.

Skills

Qualitätssicherung

Regulatorische Compliance

Validierungsprozess

Änderungsmanagement

CAPA-Systeme

Analytische Fähigkeiten

Root Cause Analysis

Dokumentation

Education

Bachelor in Life Sciences

CQE oder CQA

Tools

TrackWise

Veeva

Kneat

MasterControl

Job description

We are seeking a detail-oriented Quality Assurance (QA) Specialist to oversee and manage key quality assurance activities within the pharmaceutical or life sciences industry. This role is focused on reviewing and approving Validation Lifecycle Documentation, Change Controls, Investigations, CAPA (Corrective and Preventive Actions), and conducting Audits to ensure compliance with Good Manufacturing Practices (GMP) and relevant regulatory standards. The ideal candidate will have strong expertise in quality assurance, regulatory compliance, and a keen understanding of the validation process, investigation management, and audit systems.

Key Responsibilities:

Validation Lifecycle Documentation:

• Review and Approve Validation Protocols:
• Review and approve Validation Master Plans (VMP), IQ/OQ/PQ protocols, and Validation Reports to ensure they meet GMP and regulatory requirements.
• Ensure proper documentation of validation activities for equipment, systems, processes, and cleaning procedures.
• Verify that validation documentation adheres to regulatory guidelines (e.g., FDA, EMA) and internal quality standards.
• Oversee the execution and completion of validation activities to ensure that validation objectives are met, and results are appropriately documented.
• Monitor and Review Validation Lifecycle:
• Track the progression of validation activities throughout the lifecycle and ensure alignment with approved protocols and timelines.
• Ensure that any changes or deviations during the validation process are documented, assessed for impact, and approved appropriately.

Change Control Management:

• Review and Approve Change Controls:
• Review and approve Change Control requests related to manufacturing processes, equipment, facilities, and systems to ensure compliance with GMP and internal procedures.
• Assess the potential impact of changes on product quality, safety, and regulatory compliance, ensuring that changes are appropriately validated.
• Monitor the implementation of approved change controls, ensuring that the changes are completed and documented per established procedures.
• Ensure Change Control Documentation:
• Maintain accurate records for each Change Control, including risk assessments, justifications for the changes, and validation activities.
• Ensure that any changes that require validation or re-validation are properly documented and executed in accordance with company procedures.

Investigations:

• Lead Investigations of Deviations and Non-Conformances:
• Oversee and review investigation reports for deviations, non- conformances, and quality events in compliance with GMP standards.
• Ensure thorough root cause analysis (RCA) is performed and documented, identifying the root cause of issues related to products, processes, and systems.
• Support and guide teams in developing appropriate corrective actions and preventive actions to address the identified issues.
• Ensure Timely Resolution and Documentation:
• Ensure that investigations are completed in a timely manner and that proper documentation is maintained in line with GMP requirements.
• Review investigation reports to ensure they are accurate, complete, and in compliance with regulatory expectations.

CAPA (Corrective and Preventive Actions):

• Review and Approve CAPA Plans:
• Review and approve CAPA plans resulting from investigations, audits, deviations, or non-conformances to ensure they are adequately addressing the root cause.
• Ensure that CAPA actions are documented, executed, and tracked to completion, verifying that corrective actions have been effectively implemented.
• Assess the effectiveness of CAPA actions through follow-up activities, audits, and review of quality metrics.
• Track and evaluate the effectiveness of implemented CAPA actions and ensure that preventive measures are sustained to avoid recurrence.
• Continuously assess CAPA performance, ensuring a proactive approach to quality improvement.

Audits:

• Conduct Internal Audits:
• Lead and conduct internal audits to evaluate compliance with GMP, SOPs, regulatory requirements, and company policies.
• Identify areas of non-compliance, gaps in quality systems, and areas for improvement, and develop corrective actions.
• Prepare and present audit findings to senior management and relevant stakeholders.
• External Audit and Regulatory Inspection Support:
• Assist with preparation for regulatory inspections (FDA, EMA, etc.) and external audits, ensuring that all required documentation and corrective actions are readily available.
• Support interactions with regulatory bodies during audits or inspections, ensuring the company is compliant with applicable regulations.
• Audit Follow-up:
• Ensure that audit findings, both internal and external, are appropriately tracked and addressed through CAPA or other corrective measures.
• Follow up on audit findings to verify that corrective actions are effective and completed within the required timelines.

We are seeking a detail-oriented Quality Assurance (QA) Specialist to oversee and manage key quality assurance activities within the pharmaceutical or life sciences industry. This role is focused on reviewing and approving Validation Lifecycle Documentation, Change Controls, Investigations, CAPA (Corrective and Preventive Actions), and conducting Audits to ensure compliance with Good Manufacturing Practices (GMP) and relevant regulatory standards. The ideal candidate will have strong expertise in quality assurance, regulatory compliance, and a keen understanding of the validation process, investigation management, and audit systems.

Key Responsibilities:

Validation Lifecycle Documentation:

• Review and Approve Validation Protocols:
• Review and approve Validation Master Plans (VMP), IQ/OQ/PQ protocols, and Validation Reports to ensure they meet GMP and regulatory requirements.
• Ensure proper documentation of validation activities for equipment, systems, processes, and cleaning procedures.
• Verify that validation documentation adheres to regulatory guidelines (e.g., FDA, EMA) and internal quality standards.
• Oversee the execution and completion of validation activities to ensure that validation objectives are met, and results are appropriately documented.
• Monitor and Review Validation Lifecycle:
• Track the progression of validation activities throughout the lifecycle and ensure alignment with approved protocols and timelines.
• Ensure that any changes or deviations during the validation process are documented, assessed for impact, and approved appropriately.

Change Control Management:

• Review and Approve Change Controls:
• Review and approve Change Control requests related to manufacturing processes, equipment, facilities, and systems to ensure compliance with GMP and internal procedures.
• Assess the potential impact of changes on product quality, safety, and regulatory compliance, ensuring that changes are appropriately validated.
• Monitor the implementation of approved change controls, ensuring that the changes are completed and documented per established procedures.

• Ensure Change Control Documentation:
• Maintain accurate records for each Change Control, including risk assessments, justifications for the changes, and validation activities.
• Ensure that any changes that require validation or re-validation are properly documented and executed in accordance with company procedures.

Investigations:

• Lead Investigations of Deviations and Non-Conformances:
• Oversee and review investigation reports for deviations, non- conformances, and quality events in compliance with GMP standards.
• Ensure thorough root cause analysis (RCA) is performed and documented, identifying the root cause of issues related to products, processes, and systems.
• Support and guide teams in developing appropriate corrective actions and preventive actions to address the identified issues.

• Ensure Timely Resolution and Documentation:
• Ensure that investigations are completed in a timely manner and that proper documentation is maintained in line with GMP requirements.
• Review investigation reports to ensure they are accurate, complete, and in compliance with regulatory expectations.

CAPA (Corrective and Preventive Actions):

• Review and Approve CAPA Plans:
• Review and approve CAPA plans resulting from investigations, audits, deviations, or non-conformances to ensure they are adequately addressing the root cause.
• Ensure that CAPA actions are documented, executed, and tracked to completion, verifying that corrective actions have been effectively implemented.
• Assess the effectiveness of CAPA actions through follow-up activities, audits, and review of quality metrics.

• Monitor CAPA Effectiveness:
• Track and evaluate the effectiveness of implemented CAPA actions and ensure that preventive measures are sustained to avoid recurrence.
• Continuously assess CAPA performance, ensuring a proactive approach to quality improvement.

Audits:

• Conduct Internal Audits:
• Lead and conduct internal audits to evaluate compliance with GMP, SOPs, regulatory requirements, and company policies.
• Identify areas of non-compliance, gaps in quality systems, and areas for improvement, and develop corrective actions.
• Prepare and present audit findings to senior management and relevant stakeholders.

• External Audit and Regulatory Inspection Support:
• Assist with preparation for regulatory inspections (FDA, EMA, etc.) and external audits, ensuring that all required documentation and corrective actions are readily available.
• Support interactions with regulatory bodies during audits or inspections, ensuring the company is compliant with applicable regulations.

• Audit Follow-up:
• Ensure that audit findings, both internal and external, are appropriately tracked and addressed through CAPA or other corrective measures.
• Follow up on audit findings to verify that corrective actions are effective and completed within the required timelines.

Requirements

Education:

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related field. Advanced degrees or certifications (e.g., CQE, CQA, Six Sigma) are a plus.

Experience:

• 3-5 years of experience in Quality Assurance within the pharmaceutical or life sciences industry, with a focus on validation, change control, CAPA, investigations, and audits.
• Experience with regulatory inspections (FDA, EMA) and internal auditing processes is highly preferred.

Knowledge:

• Deep knowledge of GMP, FDA regulations, ISO standards, and industry-specific regulations.
• Understanding of validation protocols, change control processes, root cause analysis, and CAPA systems.
• Familiarity with quality management systems (QMS), such as TrackWise, Veeva, Kneat, MasterControl, or similar platforms.

Technical Skills:

• Strong attention to detail and analytical skills to evaluate complex data, investigations, and documentation.
• Excellent written and verbal communication skills, with the ability to draft clear and concise reports.
• Proficiency with data analysis and trend analysis to monitor CAPA effectiveness and quality improvements.

Benefits

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Consulting

• Industries

  Pharmaceutical Manufacturing

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