Senior Quality Assurance Specialist
Fleming Pharmaceuticals (St Louis, Missouri)

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Fleming Pharmaceuticals, based in the greater St. Louis area, is a privately held company specializing in the development and manufacture of innovative prescription and over-the-counter therapies. Our fully-integrated Missouri facilities house liquid and solid dose manufacturing and packaging, analytical microbiological laboratories, research and development, distribution, marketing and business administration functions.

 

Senior Quality Assurance Specialist

 

Fleming Pharmaceuticals is seeking an experienced Quality Assurance professional to fill the role of Senior Quality Assurance Specialist in Fenton (St. Louis County) Missouri.  Fleming Pharmaceuticals offers a unique opportunity for an experienced Quality Assurance professional to establish new quality systems that are consistent with industry standards and regulatory requirements.

 

The ideal candidate will possess a broad range of skills and experience in Quality Systems, including:

 

Knowledge of and experience interpreting Federal Regulations and guidances  (i.e., cGMPs, 21CFR parts 210 and 211, ICH guidance documents, etc.) Implementation and management of a CAPA system to drive process improvements Implementation and management of a Vendor Qualification/Management program that encourages supplier/customer partnerships and improves change control Project Management in implementation of systems, introduction of new equipment into the facility and launching of new OTC and prescription drug products, medical foods, etc. High proficiency in a number of software applications, including the Microsoft suite of products, electronic document management systems, statistical analysis packages, databases, etc. Management of a Calibration/Preventative Maintenance program to ensure all equipment remains suitable for use in a GMP environment Development of a Validation Master Plan to ensure all appropriate processes and systems are validated and remain in that state Statistical analysis and trend identification on processes and systems within Production, Laboratory and Quality Systems Conducting training on quality systems and cGMP requirements, both in formal group and small group settings

 

The education, technical and experience requirements necessary to excel in the Senior Quality Assurance Specialist role at Fleming Pharmaceuticals include:

 

Minimum of a Bachelor of Science in a technical discipline including chemistry, biology, engineering or similar.  Preferential consideration will be given to candidates with a Master’s degree in a technical discipline or an MBA. A minimum of 5 years of experience in the pharmaceutical, API or medical device industry.  Candidates who have served roles in Quality Assurance/Quality Control or Operations are preferred. In order to be considered for the Senior QA Specialist position, any candidate must have 2+ years of experience in Quality Assurance, specifically in the development and implementation of Quality Systems. The ideal candidate will have formal training or demonstrated experience in Project Management, including serving as both a Project Lead/Manager as well as the Quality representative on cross-functional teams.

 

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

EOE