Quality Assurance Inspector

Job Summary

The In-Process Quality Assurance Inspector will meet the company goals for product quality and production efficiency. This position will ensure that Operations is following the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. As the In-Process Quality Assurance Inspector, the primary function of the position is to have Quality oversight of the Manufacturing and Production areas including Staging, Compounding, Filling, Inspecting and Labeling/Packing. Oversight includes the routine review of In-Process functions such as cleaning, weighing, filling, material status verification, compounding, batch record documentation accuracy, logbook documentation accuracy, room clearance, line clearance, room and line set-up, In-Process quality attributes.

Core Responsibilities

• Performs QA oversight of Production activities including Compounding, Filling, Inspection, Labeling and Packing.
• Oversight and confirmation of cleaning of rooms, parts, equipment and surfaces to assure compliance with cleaning requirements

• Oversight and confirmation of compliance in Compounding processes including room clearance, verification of material status, weighing, mixing, charging of chemicals, in-process quality attributes, autoclave, compliance with batch record instructions and sequence, documentation verification, logbook documentation verification.
• Oversight and confirmation in compliance of Filling Operations including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms and batch records. 
• Verification of proper gowning by all personnel in all areas of Production.
• Verification of environmental monitoring activities including plating, Lighthouse and personnel monitoring.
• Sampling, inspection, and status tagging of incoming raw material and components.
• Inspection and any other activity assigned by Quality Assurance management.
• Oversee all Quality aspects on the floor
• Product label review and approval
• Participate in regulatory audits
• Performs or assists process owners with root cause analysis
• Performs duties in accordance with established company procedures and policies; performs other duties as assigned.

Qualifications & Requirements

• 1-3 years of progressive experience within cGMP quality operations and FDA regulations or a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical experience.
• High school degree
• BS in Scientific field preferred
• 1 plus years’ experience with aseptic drug product manufacturing is required.
• A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices and Good Documentation Practices.
• Strong familiarity with manufacturing process and operations, automation, equipment/facilities validation
• Familiarity with FDA inspections and audits
• Ability to complete tasks with little direction or need for supervisory follow-up.
• Strong written, verbal and presentation communication skills.
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and other must be able to learn additional software as required).
• Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
• Work schedule flexibility.

Position Type 

• On-Site
• This is a full-time position in a compounding pharmacy with regular operations occurring between M-Th in our Ledgewood, NJ location. Working hours are 10 hours per day and may vary anywhere from several hours before opening to several hours after closing. Additionally, weekend hours may be needed depending upon workload demands. Rotating shifts as well as holidays and work during inclement weather may be required.

Travel

• None