Quality Specialist - Manufacturing

The Quality Specialist is a vital member of the Quality Team, and key partner with the Manufacturing and Formulations Team.  It is the function of the Quality Specialist to effectively perform the necessary and varied activities that ensure quality and compliance with applicable regulatory requirements in pharmaceutical manufacturing.  These activities include reviewing documents and data, conducting process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis.  May serve as quality representative for manufacturing/formulation during client audits and provide support during regulatory inspections.  Assists with the development of SOPs or other quality documents as needed.  Mentor and train other employees in quality and compliance matters.  In the support of manufacturing/formulation areas:  perform quality release of materials, products, equipment and facilities. 

Essential Job Requirements:


· Bachelors degree in Chemistry, Biology, or related field with 5+ years GMP manufacturing related experience is preferred.



· Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps well informed of new regulations and regulatory guidance in areas of expertise.

· A self-starter and the ability to act independently

· Good written and oral communication skills.

· Good computer skills and knowledge of Microsoft Office products.

· Ability to be trained and to mentor.

· Ability to interact well with employees at all levels.

· Ability to participate in audits. 


Supervision Received: Limited

Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. May determine the methods and procedures on new assignments, but still accomplishes goals within defined procedures and practices. Seeks management direction for problems of diverse and/or complex scope.


Environment and Protective Equipment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts and a high noise environment. The employee will be required to gain access to lab or manufacturing areas for inspections or work discussions.  The employee would need to be able to work with controlled substances.  The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc. 

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