JobWatch

1+ months

GMP Product Specialist

Kelly Services
Schaumburg, IL 60173
**Kelly Science is seeking a GMP Product Specialist for our client located in Schaumburg, IL**


**Pay: $60,000**


**Hours: 8am-5pm**


**GMP Product Specialist**


Perform root cause analysis on deviations, serving as primary author of deviation reports; address comments from both internal and external stakeholders on the final report


Gather Data from various sources across the site, assess events for impact to product quality, perform Trending Analysis, and perform Risk Assessments


Work closely with Departments, Quality Assurance, and support groups to develop appropriate CAPAs


Initiate appropriate corrective action/preventative action (CAPA) to prevent deviation recurrence


Successfully execute the CAPA process and conduct follow-up to the implementation of actions deriving from investigations and reviews


Act as an area/department representative in deviation discussions, coordinating activity and proposals with functional area approvers for both deviations and CAPAs


Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward


Conflict resolution, problem solving in a cross-functional setting


Management of multiple projects and concurrent timelines


Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner


Follow all cGMP guidelines and ensure all procedures are performed and documented per the applicable SOPS, policies, and regulatory guidelines


**The Ideal Candidate Would Possess**


Proficiency with technical writing in cGMP or FDA regulated manufacturing environment


Ability to work in a fast paced environment and manage multiple projects and objectives for on-time event closure


Must work well on a team and be able to troubleshoot and problem solve in a cross-functional team setting


Must be proactive, action oriented, and adapt to change


Able to identify and flag risks in a timely manner to keep deliverables on track


Strong written and verbal communication skills


Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems


Ability to understand and apply cGMP regulations as they relate to pharmaceutical manufacturing


**Qualifications**


BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline


Minimum of 1 year experience conducting investigation and root cause analysis/CAPA in a FDA/cGMP preferred


Experience with cGMP compliance in clinical/commercial manufacturing environment is preferred


**Interested? Apply Now!**


**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 (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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-06 Expires: 2021-10-11

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GMP Product Specialist

Kelly Services
Schaumburg, IL 60173

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