Quality Assurance Associate

Job Title: Quality Assurance Associate

Location: Dayton, NJ

Job Type: Full-time

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Associate. In this role, you will be responsible for performing field QA activities: in process checks in the aseptic processing area, approval for area clearance, AQL inspection for finished products, retention sampling for finished products, batch record review, final product release, review and approve operation documents and forms, and approval / rejection of in-coming raw materials, components, and final product labels. Ensure compliance of operations personnel with the company’s procedures and Good Manufacturing Practices (GMPs). This position will also be responsible for identifying any deviations or non-conformances, writing deviation reports, performing root cause analysis, writing/revising standard operating procedures and forms, and tracking metrics, when required.

 

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality.
• Perform monitoring of Compounding in the aseptic processing area.
• Perform AQL inspection for Finished products
• Perform in-coming raw material, component, and labeling inspection and release.
• Review executed batch records to ensure compliance with approved procedures, and communicate and resolve discrepancies with manufacturing operators and supervisors.
• Provide Quality support to Manufacturing personnel on the floor – providing guidance during GMP events and initiation of deviations and investigations.
• Lead small scope projects, as assigned.
• Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current with regulations and industry best practices and update SOPs to improve compliance. 
• Prepare all necessary reports in a timely manner to meet compliance requirements and business needs.
• Participate in Process Validation activities, including protocol execution and reporting, as necessary.
• Working knowledge of FDA regulations and application of GMPs.

Qualifications:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor’s degree in relevant science or engineering discipline.
• 4+ years of relevant cGMP experience.
• Hands-on experience with batch record review and product disposition.
• Hands-on experience with ERP, Documentation, and LIMS systems.
• Strong written and verbal skills.
• Demonstrated effectiveness in task completion, decision making, and problem solving
• Excellent writing and computer skills and ability to present data in a logical manner.
• Excellent interpersonal and communication skills.
• Excellent organization and time management skills.
• Ability to work in a high-paced team environment.
• Working knowledge of FDA regulations, application of GMPs. 

Preferred Qualifications:

• The qualified candidate must possess a strong background in Quality Assurance, Quality Compliance and Quality Systems.
• Experience in a 503B Compounding manufacturing environment.
• Experience in FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred.<