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QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

+ Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.

+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.

+ Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.

+ Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

+ Coordinates legal requests in support of government investigations or litigations.

+ Ensures the quality assurance programs and policies are maintained and modified regularly.

+ Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

+ Coaches and reviews the work of lower level specialists

+ Makes improvements of processes, systems or products to enhance performance of the job area.

+ Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Qualifications:

+ Bachelor's degree in related area

+ 4 years of relevant experience with Quality systems

+ Investigation and root cause analysis skills

+ Technical writing knowledge.

+ Organization and Communication skills

+ Process Validation and Computer software validation knowledge

+ Availability for 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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