Senior QA Associate

Veranova • Devens, MA

16h

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 internal procedures/policies/SOPs.

Requirements

• BS in a scientific discipline or equivalent with a minimum of 5-7 years’ experience in an FDA regulated industry OR MS in a scientific discipline or equivalent with a minimum of 3-5 years’ experience in an FDA regulated industry.
• Experience with Quality Assurance oversight and support for all phases of clinical trials.
• Experience with supporting On the Floor Walkthroughs of Manufacturing areas.
• Experience with Active Pharmaceutical Ingredients (APIs) and commercial phase pharmaceuticals.
• Experience working with Clients, direct facing and email communications
• Knowledge and previous experience with GMP, FDA regulations, ICH Q7, 21 CFR Part 11.
• Good understanding in one or more of the following areas: Quality systems, Analytical, Manufacturing
• Experience mentoring and training staff members in a Quality department.

Responsibilities

• Support Manufacturing and Quality Control operations on and off the floor, by proving QA support to operations in compliance with cGMP, ICH and ALCOA+ principals.
• Review of Executed Master Batch Records and provide documentation guidance both on the floor and off the floor for completeness, compliance and accuracy to support lot disposition.
• Perform Batch Disposition and Lot Release activities.
• Support issuance activities for Master Batch Records and other records, as needed.
• Provide final authorization for new controlled documents, such as master batch records and packaging master records.
• 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 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".
• 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.
• Perform GMP Walkthroughs for all areas of the site per procedure.
• Review of quality event records pertaining to deviations, investigations, CAPAs, CRMs and Customer Complaints.
• Represent the department during client audits and FDA inspections.
• To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Benefits

• Comprehensive health & wellness benefits.
• Access to mental health resources and wellness programs.
• Generous PTO and holiday pay policies.
• 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