Quality Assurance Associate - Batch Release

About the Job

This position is responsible for batch disposition and other quality functions in the pharmaceutical distribution center.

Job Responsibilities

Note : These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Review of Data logger communication (DLC) form along with data logger data, Packing slip and other related documents.
• Review of Certificate of analysis, Batch records, Certificate of conformance and Investigation reports.
• Coordinate with manufacturing sites for release documents and investigations.
• Perform batch disposition including return goods per current approved procedure.
• Coordinate with distribution center folks for handling of rejected batches.
• Providing details of back order batches to all manufacturing sites on daily basis to keep track of batch release timeline and provide visibility for priority items.
• Handling of temperature and humidity monitoring systems, including alerts and excursions, and coordinating with the Vendor for any requests or fixes.
• Review weekly reports of temperature and humidity of the warehouse area
• Handling of destruction of non-controlled products and controlled substance drug products.
• Handling of Quality Inspection of all incoming batches per current approved procedure
• Handling of drug product sample management.
• Support in Investigations, Deviations, CAPA, Change Control related to QA and warehouse operations
• Support regulatory inspections (FDA, DEA, VAWD / NABP, PADOH etc.)
• Ensure US Allentown distribution warehouse is in compliance following CGMP's
• Handle / carry out other QA departmental activities / projects as assigned by the supervisor.

Qualifications

Education

Experience

Knowledge and Skills

Physical Demands and Abilities

Compensation and Benefits

Salary Range - $55,000 - 70,000 USD

The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual's final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location.

Benefits include :

About the Company

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people's lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company's discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.