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29 days old

Quality Assurance Scientist (Pharmaceutical) - Greensboro, North Carolina

Kelly Services
Greensboro, NC 27413
**Quality Assurance Scientist (Pharmaceutical) - Greensboro, North Carolina**



We have an exciting opportunity for an **Quality Assurance Scientist** to work with one of our top clients in Greensboro, North Carolina whose company is focus in the pharmaceutical field!



**Summary:** The Sr. QA Scientist is an advanced level position with hands-on QA experience in a pharmaceutical environment. Working independently and under minimum supervision, the individual will be working primarily to support Quality Assurance and Quality Control. The Sr. QA Scientist, will assure products are manufactured and tested are in compliance with internal, regulatory and industry standards, meets business needs and optimizes cost in the quality organization of the manufacturing facility



**Duties and Responsibilities:**




+ Perform a wide variety of quality assurance activities to ensure compliance with internal procedures, applicable US regulatory requirements, and customer requirements for drug substances under clinical development

+ Review and may approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, test methods, specifications, stability protocols and reports

+ Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products

+ Perform approval process for analytical procedures.

+ Perform approval process for analytical protocols / reports.

+ Perform product complaints investigations

+ Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.

+ Assist with hosting and responding to client audits

+ Conduct onsite audit of contract laboratories

+ Assist with developing and maintaining companys quality system

+ Support continuous improvement of quality systems; author new, revise existing and may review department procedures and/or forms

+ Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)

+ Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits

+ Other duties as assigned and / or developed by Director, Quality Assurance



**Minimum Requirements:**




+ Bachelors of Science Desired: Bachelors of Science in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy, Engineering, or related field.

+ 10 + Years experience in a GMP regulated environment, preferably in a QC and/or analytical laboratory, with a minimum of 5 years in QA.

+ Minimum of 3 years handling quality system investigations, CAPA, change control, etc.

+ Works independently with minimum supervision to accomplish goals

+ Good working knowledge and understanding of 21 CFR Parts 210, 211, and ICH Q7

+ Relies on extensive experience and judgment to resolve simple to moderately complex issues

+ Excellent verbal and written communication skills

+ Other Experience/Skills:

+ Root-Cause Investigation and Statistical Analysis Experience.

+ Regulatory compliance and/or previous regulatory audit experience.

+ Experience conducting onsite audits of contract laboratories



**QUESTIONS? Contact Kevin at kevin.lau@kellyscientific.com or 623-688-2142**




**Why Kelly** **** **?**



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. 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2020-12-28 Expires: 2021-02-25

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Quality Assurance Scientist (Pharmaceutical) - Greensboro, North Carolina

Kelly Services
Greensboro, NC 27413

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