Manufacturing - Quality Assurance Associate

• 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 complaintsEducation 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

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”