Senior Quality Assurance Associate

Veranova L P • Devens, MA

1d

About The Position

Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: Ensure compliance with all relevant laws and regulations as well as Veranova procedures, policies, and SOPs. The incumbent has first line responsibility for assuring that on a day-to-day basis, established procedures are followed by production, commercial and testing personnel (often through the employment of audits) Provide guidance in the sampling of the DI water systems and coordinate the sanitization and testing of the DI water system Exercise independent judgment utilizing generally defined practices and policies to make sound, logical decisions and propose effective solutions to complex problems. Ensure on-time disposition and delivery of all raw materials, in-process and finished drug substances Analyze systems and propose system quality improvements as needed Provide final authorization to production of batch records to begin processing and review andfinal close out of completed batch records Ensure that all test results meet established specifications before either raw material, in-process materials or finished drug substances are "released" Develop, review, approve and maintain all documentation required to support effective QA/QC procedures and audits Provide final authorization for new controlled documents, such as master batch records and packaging master records Ensure proper training of all production operators and technicians on existing, new and revised policies and procedure. Conduct cGMP training sessions based on trend analysis and audit findings as required Assist in ascertaining the cause of any non-conformances and institute corrective actions. Track deviations, compile, and distribute periodic reports. Complete other related duties as directed

Requirements

• BS in Chemistry or closely related science is required
• A minimum of 5 years in QA/QC/Compliance in an FDA/DEA regulated environment or a minimum of 5-7 years in API manufacturing in and FDA/DEA regulated environment is desired

Responsibilities

• Ensure compliance with all relevant laws and regulations as well as Veranova procedures, policies, and SOPs.
• Assuring that on a day-to-day basis, established procedures are followed by production, commercial and testing personnel (often through the employment of audits)
• Provide guidance in the sampling of the DI water systems and coordinate the sanitization and testing of the DI water system
• Exercise independent judgment utilizing generally defined practices and policies to make sound, logical decisions and propose effective solutions to complex problems.
• Ensure on-time disposition and delivery of all raw materials, in-process and finished drug substances
• Analyze systems and propose system quality improvements as needed
• Provide final authorization to production of batch records to begin processing and review andfinal close out of completed batch records
• Ensure that all test results meet established specifications before either raw material, in-process materials or finished drug substances are "released"
• Develop, review, approve and maintain all documentation required to support effective QA/QC procedures and audits
• Provide final authorization for new controlled documents, such as master batch records and packaging master records
• Ensure proper training of all production operators and technicians on existing, new and revised policies and procedure.
• Conduct cGMP training sessions based on trend analysis and audit findings as required
• Assist in ascertaining the cause of any non-conformances and institute corrective actions.
• Track deviations, compile, and distribute periodic reports.
• Complete other related duties as directed

Benefits

• Health & Wellness : Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness : Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
• Professional Development : Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• I nclusive Culture : At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don’t meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees