QA Specialist

Quality Assurance Associate

Onsite position - shift - Mon-Fri 6AM - 2:30PM + 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