Quality Assurance Specialist - Drug Product

Role Summary

Quality Assurance Specialist – Drug Product is an onsite role based in Northborough, MA. The position focuses on ensuring GMP compliance, conducting QA activities across the product lifecycle, and supporting regulatory inspections to maintain product quality. This role requires working onsite Monday–Friday, 1st shift.

Responsibilities

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
• 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
• 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)

Qualifications

• Required: 2+ years of experience in quality assurance within the pharmaceutical industry
• Required: Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
• Note: A combination of education and experience will be considered.

Skills

• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in all quality assurance activities
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• Proficiency in identifying problems and implementing effective corrective actions
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

Education

• Bachelor's degree in engineering or related field - preferred.