At ProPharma Group, we work with clients in the pharmaceutical, biotechnology and medical device industries throughout the United States to provide the best solutions for their unique challenges and concerns. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes. Our goal is to provide the information our clients need to deliver safe, effective and quality products and services every time.
Several positions exists for Quality Assurance or Compliance / Quality Engineers at ProPharma Group operating in the Far West. The position will be responsible for the quality processes for our Clients within the Life Science industry. This position provides Quality oversight of operations and data review for accuracy, completeness, and conformance to current Good Manufacturing Practices (cGMP) and company quality standards. This individual may also be responsible for providing training, executing audits, document creation, communication, and oversight to meet the established quality goals of the client and applicable regulations. This project is a 3-6 month contract opportunity. Must be familiar with preparing and maintaining technical files for CE Marked products. Medical device experience and knowledge of CFR 820 and ISO13485 quality systems is required. In addition, “hands-on” positions are available for qualified quality engineers experienced with updating product registrations with foreign regulatory agencies.
Qualified candidates will possess a Bachelor’s degree in scientific or engineering discipline along with 3 plus years related industry experience.
Proficient in Microsoft Word, Excel, Power Point and Project.
General knowledge of quality system elements and cGMP regulations.
Knowledge of CFR 820 and ISO13485
Experience with CE Mark technical file development and maintenance.
Experience providing support to clients with quality issues such as OOS results, deviations and non-conformances arise. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.
Ability to write and revise Standard Operating Procedures.
Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
Carry out duties and responsibilities with limited supervision.
Flexibility to work occasional weekends and evenings.
Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
Ability to plan and manage own work
Must be willing to travel regionally and/or nationally throughout the US.
All candidates must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical...