Quality Assurance Specialist Jobs

Quality Assurance Specialist

Our client is looking to hire a Quality Assurance Specialist who will be responsible for assisting with the maintenance of an independent quality system to support bio-analytical lab operations, identify areas of regulatory risk and bring these to the attention of Quality Management.

The Perks!

• Perks - lots of autonomy and very flexible work environment. Very collaborative culture from the top down.
• Compensation - 60-70k annually
• Benefits- generous benefits package

Responsibilities of the Quality Assurance Specialist:

• QA support including Enterprise Quality Management Software (EQMS) validation, specification and other quality document development.
• Support in vendor qualifications.
• Day-to-day tactical execution of Quality Assurance (QA) plans and reviews.
• Develop, maintain, and periodically update SOPs and policies that govern the day-to-day tasks of the QA function.
• Coordinate department and cross-department risk assessments.
• Develop, review and approve QA documents.
• Coordinate resolution of Corrective Action Preventative Action (CAPA), deviations and change control.
• Develop and implement regulatory compliance training programs, electronic learning and training management systems.
• Support Summit Analytical in internal and external audits.
• Support Summit Analytical Management in day-to-day quality compliance needs.

Skills and Knowledge:

• Strong communication abilities, and organizational skills.
• 4-year degree in biological science, health science or similar discipline.
• Minimum of 2 years experience in Quality Assurance within the clinical trials industry
• Advanced degree preferred.

About the Company:

Summit Analytical’s rich history of client services dates back to 2002 when Jim Rogers founded Summit Analytical in Colorado. Mark Jaros joined Summit Analytical part-time and then transitioned to full-time as a managing member in August 2009.

Summit Analytical’s statistical consulting practice has evolved to support many domestic and international clients across multiple therapeutic areas such as acute and chronic pain studies, vaccines, wound healing, fibromyalgia, oncology, endocrinology, cardiovascular, and neurology, as well as post-marketing expertise supporting medical affairs and life cycle extensions for multiple products. Summit Analytical also completed post-marketing support to OTC clients on many advertising claims (e.g., weight loss, metabolism, sports performance, and natural products).

Summit Analytical has extended our history and expertise with CDISC (CDASH, SEND, SDTM, and ADaM) implementation and support to meet evolving regulatory standards for statistical sciences and standard data submissions. We continued to extend our service offerings with pharmacokinetic analyses and statistical and medical writing, including manuscript preparation.

Summit Analytical, through its history has solidified its roots as a niche partner supporting pharmaceutical, biotechnology, and device companies with customer centered statistical consulting, statistical programming, and regulatory data sciences.

Come Join Their Team!

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