Senior QA Associate

Veranova L P • West Deptford Township, NJ

20h

About The Position

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.

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 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.

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.

Benefits

• Comprehensive health & wellness benefits.
• Access to mental health resources and wellness programs.
• Generous PTO and holiday pay policies.
• Competitive base salary.
• Eligibility for performance-based bonuses.
• Attractive 401(k) Plan with company match.
• Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
• Tuition Assistance for Undergraduate and Graduate degree programs.

What This Job Offers

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