Manufacturing - Quality Assurance Associate

Job Description

Job Description

TEMP TO HIRE - DURATION - 6 MONTHS - ONSITE POSITION - SHIFT - MON-FRI 2PM - 10:30PM + MANDATORY OVERTIME.
•             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 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

 

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