Senior Quality Assurance Associate

The Senior QA Associate will perform on the floor walkthroughs of Manufacturing and Quality Control areas to drive Inspection Readiness activities. They will also perform review and release of Active Pharmaceutical Ingredients (APIs) in support of clinical and commercial product manufacturing, as well as assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities. This person must also maintain a high level of strict GMP compliance. 

Core 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. 
• Collaborate with manufacturing operators on the resolution of issues, non-conformities, and deviations.
• 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. 
• Recommend the stop of manufacture and/or distribution of product if necessary.
• Support issuance activities for Master Batch Records and other records, as needed.
• Perform GMP Walkthroughs for all areas of the site per procedure. 
• Perform Product Change Over (PCO) activities for the production suites.   
• Review of Trackwise records pertaining to deviations, investigations, CAPAs, CRMs and Customer Complaints. 
• Write and revise Standard Operating Procedures (SOPs) as required.
• Initiate and participate in process improvement activities for quality processes to enhance compliance and efficiency, which may include revision of QA relevant SOPs and review and/or approval of site wide SOPs and other documents.
• Work directly with production, project management, and quality control to ensure that deliverables meet quality requirements.
• Represent the department during client audits and FDA inspections.
• Assist with overseeing QA Associate I and QA Associate II personnel.
• Assist in the scheduling and maintenance of Quality Assurance activities and systems.
• Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities.
• To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed. 

Qualifications:

Required

• 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 performing Batch Record Review, Disposition and Release activities
• Experience with Active Pharmaceutical Ingredients (APIs) 
• Experience working with Clients, direct facing and email communications 
• Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations. 
• Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.
• Good understanding in one or more of the following areas: Quality systems, Analytical, Manufacturing 
• Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals.
• Experience mentoring and training staff members in a Quality department.
• Experience with Microsoft Office and other complex computer software.
• Experience with commercial phase pharmaceuticals.
• Strong problem-solving skills and the ability to make decisions quickly.
• Excellent written and verbal communication skills.
• Strong collaboration background for providing on the floor support to key areas of the site. 
• Strong technical writing skills.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

 Preferred

• Experience with Trackwise and Master Control (preferred).