This is Vydehi from Intellectt Inc. We currently have an opening for a QA Associate I with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at +1 732 355 7412.
Job Title: QA Associate I
Location: Winchester KY
Duration: 06 Months
Shift Timings: Mon- Fri (2PM - 10:30PM)
Description
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 Client 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 Client 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.
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
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
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