Senior QA Associate

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.

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

Role Overview:

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.

Core 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. a. 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.

Qualifications:

• 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 discretionally 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.

Salary Range:$90,000-$115,000 annual base salary.

The salary range for this role is $90,000-$115,000. 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,…