Job Details
Posted 18 June, 2026
Job Id: 628546
Quality Assurance Associate (days)
Job Description
Pay: 22.94/hr
* 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
Education or Equivalent Requirements:
Minimum education and experience required to perform the job:
Quality Assurance Associate
* Bachelors degree; OR
* Associates with 1 year of related work experience; OR
* High School Diploma/GED with 2 years of related work experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
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