Manufacturing - Quality Assurance Associate

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
  
  

Important Notice: Protecting Your Information

Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.

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