Quality Assurance Associate

Payrate: $26.38 - $26.38 /hour.

Summary: This position involves ensuring compliance with SOPs, cGMP, and CFR guidance in the manufacturing of solid oral dosage pharmaceutical products.

Responsibilities:

• Recommend SOP and batch record changes as needed.
• Review proposed SOP revisions and provide feedback to management.
• Conduct real-time audits 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.
• Conduct 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 applicable to manufacturing.
• 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 to identify and resolve routine errors and prevent possible deviations.
• Work cross-functionally to assess the impact of potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise, providing sufficient detail for a full investigation by the responsible department.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards).
• Assist in investigations for deviations by supporting data gathering and root cause analysis.
• Enforce GMP Compliance and promote teamwork and good communication.
• Provide training and coaching to manufacturing staff as needed.
• Support site process improvements, including training, efficiency projects, and implementation of CAPAs.
• Complete investigations of customer complaints.

Payrate: $26.38 - $26.38 /hour.

Summary: This position involves ensuring compliance with SOPs, cGMP, and CFR guidance in the manufacturing of solid oral dosage pharmaceutical products.

Responsibilities:

• Recommend SOP and batch record changes as needed.
• Review proposed SOP revisions and provide feedback to management.
• Conduct real-time audits 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.
• Conduct 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 applicable to manufacturing.
• 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 to identify and resolve routine errors and prevent possible deviations.
• Work cross-functionally to assess the impact of potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise, providing sufficient detail for a full investigation by the responsible department.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards).
• Assist in investigations for deviations by supporting data gathering and root cause analysis.
• Enforce GMP Compliance and promote teamwork and good communication.
• Provide training and coaching to manufacturing staff as needed.
• Support site process improvements, including training, efficiency projects, and implementation of CAPAs.
• Complete investigations of customer complaints.

Qualifications:

• Bachelor s degree; OR Associate s degree with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience.
• Strong attention to detail, excellent communication skills, ability to work in a team environment, and a proactive approach to problem-solving.

Pay Transparency: The typical base pay for this role across the U.S. is:$26.38 - $26.38/hour
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