Quality Assurance Auditor
Company : Kelly
Country: United States
Location : Boston, Massachusetts
Post: Sat, 11 Sep 2021 05:12:12 GMT
Expires: Mon, 11 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Science & Clinical is seeking QUALITY ASSURANCE AUDITOR professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all. If youre passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.
Will perform GxP audits of pharmaceutical manufacturing, packaging/ labelling, laboratory controls, technical services, storage &distribution and quality systems for sterile/non-sterile APIs, drug products, medical devices, combination products, packaging materials and services.
GxP audits are normally taken place in the US. They are scheduled, prepared, conducted and followed up by the auditor based on company annual audit work plan and agreed GMP standards.
Scope of the position includes external Vendor audits and internal Global Risk Assessment (GRA) audits of company sites, however the primary focus will be companys internal Global Risk Assessment audits and companys critical CMO vendors.
* Scheduling, preparation, conduct, documentation and follow-up of assigned GxP audits in accordance with the company corporate standards/
* Initial assessment of audit deficiencies, corrective and preventive actions, and overall vendor/site compliance status based on regulatory GMP requirements and specific company requirements.
* Communication to stakeholders on potential risk and product impact from observations and GMP deficiencies found during your audits.
* Provide support to company site with supplier qualification issues and supplier risk assessment based on audit result when required/requested.
* Support notification to management process in case of critical audit findings in collaboration with audit regional lead and audit plan owner.
* Regular participation in GMP trainings (internal/external).
* Bachelors degree in Engineering or Science or related scientific discipline, or equivalent. Higher degree/PhD will be preferred for senior level positions.
* Relevant regulated industry experience (i.e. FDA or EMA).
* Experience working at the FDA is highly preferred.
* Experience filing IND/NDA submissions (check which Phase of Clinical Development the talent has, or the client requires).
* Experience with interacting with specific Divisions within the FDA (i.e., CDER or CBER).
* Knowledgeable of FDA Clinical Trial Guidance’s and regulations, pharmaceutical development process, and industry standard practices.
* Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary report.
* Regulatory correspondence with PI’s and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates.
* Maintain TMF related to ongoing studies and all regulatory documentation.
* Working knowledge of database management programs, analytical tools, and CTMS.
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly
At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. [
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