QA Specialist

ONSITE POSITION - SHIFT - FRI, SAT, SUN 6PM - 6AM + 1 DAY EVERY OTHER WEEK + 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 client 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