The Quality Assurance Associate is a critical role within the quality assurance team, responsible for managing and resolving non-product quality issues across all three manufacturing sites: Mumbai, Panoli, and Dehradun. This position is vital in ensuring that quality control procedures are strictly adhered to, and it plays an instrumental role in maintaining the organization's commitment to product excellence. The QA Specialist will act as the primary point of contact for non-conformance issues, collaborating with cross-functional teams to resolve any discrepancies that may arise during the production process.

What we’re looking for

• Education: M.Sc (Chemistry)
• Experience: Minimum 3 years experience in Quality Assurance

How you will thrive and create an impact:

The role involves a significant focus on continuous improvement, aiming to reduce the frequency of non-product quality issues by addressing the root causes and implementing corrective actions. The specialist will lead initiatives to optimize processes, ensuring that best practices are followed across all sites. This includes conducting investigations into customer complaints, working closely with site managers and production teams to understand and address the underlying issues, and ensuring that all corrective actions are taken in a timely and efficient manner.

The QA Specialist will also oversee key components of the Quality Management System (QMS), ensuring that the organization remains compliant with relevant industry standards and regulatory requirements such as ISO 9001:2015, GMP, and GDP. Additionally, the role will include management of document control processes, ensuring that all necessary documentation is current, accurate, and accessible for internal and external audits. The QA Specialist will take ownership of audit preparations, working to always maintain audit readiness.

As a subject matter expert, the QA Specialist will provide guidance and support across the manufacturing sites, leading training initiatives and offering expert advice to staff in order to foster a culture of quality and compliance. By driving continuous improvement and reinforcing the company's commitment to operational excellence, the QA Specialist will help to ensure that all production processes meet the highest standards of quality while meeting customer expectations.

In summary, the QA Specialist is a key player in maintaining the integrity of the quality system across all manufacturing sites, providing leadership on corrective actions, driving continuous improvements, and ensuring regulatory compliance throughout the organization.

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

Key Responsibilities of the Position:

Non-Product Quality Issue Management:

• Identify, document, and resolve non-product related quality issues across the Mumbai, Panoli, and Dehradun manufacturing sites.
• Ensure compliance with established quality control procedures, work instructions, and GMP standards.
• Monitor and address non-conformance issues to prevent recurrence, coordinating with relevant teams and departments.

Site Coordination & Communication:

• Serve as a liaison between the three manufacturing sites, ensuring smooth communication and effective resolution of non-product quality issues.
• Collaborate with site managers, production teams, and quality specialists to ensure consistent quality control practices across all sites.

Compliance with Regulatory Requirements:

• Ensure actions taken to address non-product quality issues comply with internal policies and external regulatory requirements (e.g., GMP, ISO).
• Perform audits, review documentation (e.g., COA/COC), and ensure adherence to quality standards at all times.

Root Cause Analysis and Corrective Actions:

• Utilize problem-solving tools like 5M+E and 5 Why’s to identify root causes of non-product quality issues.
• Implement corrective actions across all three sites to ensure issues are effectively addressed and do not recur.

Continuous Improvement:

• Drive continuous improvement initiatives to optimize processes and reduce non-conformance issues.
• Collaborate with site-specific and regional teams to improve overall product quality and operational efficiency.

Documentation and Reporting:

• Oversee the documentation of non-product quality issues and track trends to ensure timely resolution.
• Prepare and maintain accurate and timely reports on quality control activities and issues identified across all sites.

Customer Complaint Investigations:

• Lead and manage all investigations related to customer complaints, ensuring thorough root cause analysis and timely resolution to improve customer satisfaction.

Audit Oversight:

• Oversee internal and external audits to ensure compliance with ISO 9001:2015, Medical Devices, GDP, and other relevant standards.
• Serve as the appointed Lead Auditor for relevant certifications, ensuring audits align with regulatory requirements.

Quality Management Systems (QMS):

• Develop, implement, and maintain the QMS to ensure compliance with ISO regulatory standards.
• Drive the continuous improvement of the QMS by incorporating best practices, process enhancements, and risk mitigation strategies.

Document Management:

• Oversee the document control system to ensure all documentation is up-to-date, compliant, and easily accessible for review during audits.

ETQ System Development and Training:

• Lead the development and training of the ETQ system across the DC IND to ensure teams are proficient in system usage for quality management and compliance.

Quality Culture and Continuous Improvement:

• Foster a culture of continuous improvement at the IND manufacturing site, guiding cross-functional teams to optimize quality performance.
• Spearhead quality improvement initiatives, encouraging a culture of excellence across all operations.

Third-Party Logistics & Warehouse Audits:

• Oversee audits of third-party logistics providers and extended warehouses, ensuring compliance with quality standards and regulatory requirements.

Certification Management:

• Lead and maintain certification audits to ensure compliance with ISO and industry-specific standards.
• Ensure the organization consistently meets regulatory demands.

Essential Skills and Qualifications:

• Extensive experience in quality assurance within regulated industries (ISO 9001:2015, Medical Devices, GDP).
• Strong knowledge of QMS, audit processes, and document control.
• Proven ability to lead and manage cross-functional teams in driving continuous improvement and compliance.
• Strong analytical skills, with experience in customer complaint investigations.
• Certification in ISO lead auditing or similar credentials.
• Excellent communication, leadership, and training skills.

Support Label Replacement Requests:

• Work closely with the supply chain led to support label replacement requests.
• Coordinate actions related to containment and corrective actions if needed to address any quality issues.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation