QA Associate 1

Job Title : QA Associate 1

Location : Winchester, KY

Duration : 6 Months on w2 (Temp to Hire)

SHIFT : SUN-THURS - 10PM - 6 : 30AM -

TRAINING ON 1ST SHIFT MON-FRI 6AM - 2 : 30PM.

Overview :

The QA Associate is responsible for quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. Key responsibilities include oversight of manufacturing operations (per cGMP, CFR, and SOP) through document review / approval, real-time monitoring / approval of manufacturing activities, and testing / approval of in-process and finished product samples.

Specific Tasks, Duties, and Responsibilities :

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

• 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 team work 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

Essential Skills and Experience :

Preferred : Bachelor s Degree in a related science or technical field plus 2 years of relevant work experience.

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

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

Knowledge / Skills Requirements :