Website Abacus Service Corporation
Abacus Service Corporation
Company : Abacus Service Corporation
Description/Comment:
– ONSITE POSITION – TEMP TO HIRE – DURATION – 3 + MONTHS – MON-FRI – 2PM-10:30PM
I. 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:
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
" 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.
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" 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:
" Bachelor’s Degree in related science or technical field preferred with 2 years prior work
experience
" Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP
manufacturing environment.
" Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.
Knowledge/Skills Requirements:
" Familiarity with basic laboratory instrumentation
" Safe work habits
" Basic math and computer skills
" Good communication skills
" Ability to follow written and verbal instructions
" Able to work with limited supervision for routine tasks
" Excellent documentation and handwriting skills
" Proficient reading and comprehension skills
" Sound decision-making, technical and problem-solving skills
" Good time management skills
" Expert technical writing and problem-solving skills
" Good Laboratory Practices
" Experienced with continuous improvement techniques
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: