Senior QA Associate

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. Every role at Veranova plays a part in delivering an exceptional customer experience through ownership and integrity.

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.

About the role

This position is responsible for monitoring the day-to-day use of established control procedures to ensure compliance of manufacturing and testing activities within the Pharmaceutical Materials unit with the requirements of the applicable laws and regulations of the countries/regions where Veranova products are marketed (i.e., USA and European Union) and Veranova Pharmaceutical Materials internal procedures/policies/SOPs.

Responsibilities

• 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).
• 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 of all raw materials, in-process, intermediates, 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 and final 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".
• Review and approve investigations, deviations, and change controls; ensuring appropriate root cause analysis methodologies are applied and that effective CAPAs are identified and implemented.
• 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 procedures.
• 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 an FDA/DEA regulated environment is desired.
• The ability to exercise sound discretionary judgment, prioritize multiple competing tasks, and work with minimal supervision.
• Experience working within a Contract Development & Manufacturing Organization (CDMO) environment, supporting both new and commercial products, with demonstrated ability to effectively communicate and collaborate with clients is highly preferred.

Pay

The salary range for this role is $90,000-$115,000 annually. This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance.

Benefits

• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness: Competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive 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. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.

Applicants for this role must be authorized to work in the United States without further employer sponsorship.