11 days old

Quality Assurance Associate _ Winchester, KY

Kelly Services
Winchester, KY 40392

Kelly Services is currently seeking Quality Assurance Associate for one of our top clients in Winchester, KY

As a Quality Assurance Associate placed by Kelly Services you will be responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit.

The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and company SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.


+ Recommend SOP and batch record changes as needed

+ Material testing, document review and SOP's.

+ Review proposed SOP revisions and provide feedback to management

+ Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters

+ Perform room and equipment clearances per procedure following cleaning conducted by production.

+ Perform microbial swabbing of equipment and room surfaces for environmental monitoring.

+ Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.

+ Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.

+ Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.

+ Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.

+ Initiate deviation problem reports in TrackWise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.

+ Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)

+ Other assignments as needed within the scope of QA Associate training curriculum.

+ Assist in investigations for deviations by supporting data gathering and root cause analysis

+ Enforcement of GMP Compliance.

+ Promotes teamwork and good communication.

+ Provide training and coaching to manufacturing staff as needed

+ Support site process improvements (training, efficiency projects, implementation of CAPAs)

+ Supports customer complaint investigation by performing inspection of retains and complaint samples

+ Monitor compliance to DEA requirements related to the manufacture, storage and handling of controlled substances


+ Preferred - Bachelors Degree in related science or technical field in combination with 2 years prior relevant work experience.

+ Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.

+ Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.

+ Strong communications skills are key.

+ Very detailed oriented and organized.

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

**Why Kelly?**

+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire

**Apply Today!**

_*Available for purchase and administered by a designated third-party vendo_

**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-09-07 Expires: 2020-10-08

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Quality Assurance Associate _ Winchester, KY

Kelly Services
Winchester, KY 40392

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast