Quality Assurance Associate

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* Job Title:

** Quality Assurance Associate

** Location** :
Winchester, KY - ONSITE

** Duration:
** Temp to Hire after 6 months

** Pay:**  $26.38/HR

** Shift:
** FRI, SAT, SUN 6PM - 6AM + 1 DAY EVERY OTHER WEEK + MANDATORY OVERTIME.

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* Position Overview:

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* - Recommend SOP and batch record changes as needed

- 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)

- Completes investigations of customer complaints

** Minimum education and experience required to perform the job:*
* - Bachelors degree; OR

- Associates with 1 year of related work experience; OR

- High School Diploma/GED with 2 years of related work experience

** Why Kelly?*
* Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism.

Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

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
* As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable…