Website Abacus Service Corporation
Abacus Service Corporation
Company : Abacus Service Corporation
Description/Comment:
– TEMP TO HIRE – ONSITE POSITION – SHIFT – FRI, SAT, SUN 6PM – 6AM.
Position Overview:
The QA Associate is 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 Catalent SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
II. 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 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 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
III. Essential Skills and Experience:
Education or Experience: (Minimum required to perform job)
" Preferred – Bachelor’s 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.
Start Time:
12:00 AM
Hours:
8:00am to 5:00pm
Location:
110 1100 Enterprise Drive (phone number removed) Winchester KY 40391 United States
Education:
Additional Job Details: