Manager Quality Assurance - Cincinnati, OH

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

 

This position is responsible for the facilitation and management of operational Quality Assurance functions, which includes batch record issuance, batch record review, product disposition, shop floor support, raw material release, calibration and maintenance record review and approval, in-process inspections, and other operational quality requirements. Additional responsibilities include effectively executing compliance audits of product/component documentation, issuance of appropriate status to components and product, participation in investigations, trending of quality issues as appropriate, and supporting data collection and department reporting activities to support both the GMP and regulatory requirements of the product.

 

• Responsible for the daily management and development of direct and indirect reports supporting quality operations and shop floor resolution of issues, including participation in deviation reports
• Responsible for coordinating and participating in the development, implementation and maintenance of quality assurance systems to ensure compliance with FDA regulations.
• Responsible for managing all information necessary to include investigations for the proper decisions on approval or rejection of all components, drug product containers, in-process materials, packaging materials, labeling and drug products manufactured.
• Responsible for the review and approval of standard operating procedures, master production records and EAM system management.
• Responsible for management of retain inventory throughout the specified retention period for all commercial products.
• Responsible for developing, implementing and maintaining training plan and curriculum to assure compliance with applicable regulatory requirements.
• Responsible for compliance to in-house specifications/standards and Good Manufacturing Practices including maintaining related documentation (eg acceptance specifications, test methods, batch records) and ensuring the company stays current of new developments related to Good Manufacturing Practices and the quality functions.
• Responsible for the review of production processes and records to assure quality; analyze trends.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures(SOP’s) and Batch Record instructions.
   

Your experience and qualifications

 

Required:

• Requires Bachelor’s Degree, preferably in a scientific or engineering discipline, or equivalent relevant experience 
• Minimum of 5 years relevant progressive experience in the pharmaceutical manufacturing or related industry 
• Minimum of 3 years supervisory or management experience required, preferably in manufacturing or related industry
• Experience with and knowledge of regulations and practices within a heavily regulated industry, pharmaceutical, medical device or related industry preferred

 

Preferred:

• Strong audit experience
• Strong documentation assessment experience
• Experience with regulatory inspections
• Understanding of internal auditing processes
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS and TrackWise.

Enjoy a more rewarding choice

 

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

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