Job Title: Quality Assurance Specialist
Location: Pearl River, NY
Main Responsibilities:
Provide direct shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs.
Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
Conducting regular audits of production processes to identify and address potential quality issues
Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
Managing and resolving quality-related issues in a timely and effective manner
Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
Leading root cause analysis investigations for quality incidents and implementing preventive measures
Participating in internal and external audits and regulatory inspections providing support and documentation
Developing and implementing risk management strategies to mitigate potential quality issues
Fostering a culture of quality and continuous improvement across the organization
Key roles (D,A,I)
Request corrections when GMP rules are not respected (D)
Prioritize quality and compliance objectives (A)
Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
Request quality improvement initiatives and strategies (D)
Identify discrepancies and corrective/preventive actions that need to be taken (D)
Escalate to upper management any failure in GMP execution on shopfloor (I) Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
Advise on how to present a topic and answer specific questions (A)
Advise on risk management strategies and plans (A)
Advise on initiatives to promote a quality-focused culture (A)
About You
Bachelor's degree with minimum 2 years of quality assurance experience, OR associate degree with 3+ years of quality assurance experience.
Comprehensive knowledge of Good Manufacturing Practices (GMP) and quality assurance principles.
Proven ability to analyze complex data sets, identify trends, detect issues, and develop effective solutions.
Demonstrated high level of accuracy and meticulous attention to detail in all quality assurance activities.
Expertise in identifying quality issues and implementing effective corrective and preventive action
Proficiency in large scale single-use bioreactor technology
Proficiency in Power BI and AI applications, and a willingness to adopt emerging technologies
Why Choose Us
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
North America Applicants Only
The salary range for this position is:
$69,000.00 - $99,666.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .
