Associate Quality Assurance

Integra LifeSciences Corporation; Indiana (PA); On-site; USD 70,000 - 100,000; Full time

Job summary

Integra LifeSciences Corporation seeks an Associate Quality Assurance professional to lead nonconformance investigations and CAPA within GMP-regulated environments. You will support manufacturing operations, collaborate with cross-functional teams, and drive sterility assurance programs to uphold patient safety and product quality.

The role emphasizes leadership, regulatory knowledge, and strong communication to navigate FDA/EMA expectations and continuous improvement initiatives across aseptic

Qualifications

• Bachelor’s degree in a related field.
• 5+ years of QA experience in pharma/biotech/medical devices.
• Experience with nonconformance investigations, CAPA, and GMP regulations.
• Knowledge of aseptic processing and sterility assurance principles.
• Strong leadership, problem-solving, and communication skills.
• Familiarity with FDA, EMA, and international regulatory requirements.
• Fluent in French and English.

Responsibilities

• Oversee nonconformance management: identify, document, investigate, and close events with root-cause analysis and CAPA.
• Provide QA oversight to manufacturing operations and support cross-functional teams to resolve quality issues.
• Oversee sterility assurance programs for aseptic manufacturing and ensure compliance with global regulatory requirements.
• Lead and mentor QA personnel, support internal audits and regulatory inspections, and promote a culture of quality.

Skills

Leadership

Problem-solving

Communication

Fluent in French

Fluent in English

GMP Regulations

Education

Bachelor's degree in Biology/Microbiology/Chemistry/Pharmaceutical Sciences/Engineering

Job description

## Associate Quality AssuranceApplylocations: CH-xx-Le Locle-191-Facilitytime type: Full timeposted on: Posted Todayjob requisition id: JR-5959Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.# The Associate Manager, Quality Assurance is responsible for overseeing quality systems and ensuring compliance with regulatory requirements and company standards. This role provides leadership for nonconformance investigations, production quality support, and sterility assurance activities to maintain product quality, patient safety, and operational excellence.## Key Responsibilities### Nonconformance Management* Supervise the identification, documentation, investigation, and closure of nonconformance events.* Ensure timely root cause analysis and implementation of corrective and preventive actions (CAPA).* Review and approve investigation reports to ensure compliance with GMP and internal procedures.* Monitor quality metrics and identify trends requiring escalation or improvement.### Production Quality Support* Provide Quality Assurance oversight and support to manufacturing operations.* Partner with Production, Engineering, Validation, and Supply Chain teams to resolve quality issues.* Review batch records, deviations, and change controls to ensure product disposition decisions are made appropriately.* Support process improvements while maintaining regulatory compliance.### Sterility Assurance* Oversee sterility assurance programs for aseptic manufacturing processes.* Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory requirements.* Review environmental monitoring data, media fills, and contamination control strategies.* Collaborate with microbiology and manufacturing teams to investigate sterility-related events and implement corrective actions.### Leadership and Compliance* Supervise and mentor QA personnel to ensure effective performance and professional development.* Support internal audits, regulatory inspections, and customer audits.* Promote a culture of quality and continuous improvement.* Ensure adherence to quality policies, procedures, and documentation practices.## ## Qualifications* Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or a related field.* 5+ years of experience in Quality Assurance within pharmaceutical, biotechnology, or medical device manufacturing.* Experience with nonconformance investigations, CAPA, and GMP regulations.* Knowledge of aseptic processing and sterility assurance principles.* Strong leadership, problem-solving, and communication skills.* Familiarity with FDA, EMA, and international regulatory requirements.* Fluent in French and English## ## Preferred Qualifications* Previous supervisory or people-management experience.* Experience supporting aseptic or sterile manufacturing environments.* Knowledge of risk management tools and continuous improvement methodologies.**Unsolicited Agency Submission**Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.### About Us**Whatever your specialty, you’ll find an ideal setting for building a rewarding career.**Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.