Job Title: QA Associate
Regular Hours (SHIFTS)
1. MON-FRI 6AM - 2:30PM.
2.FRI, SAT, SUN 6PM - 6AM.
3. FRI, SAT, SUN 6AM - 6PM.
Duration- 6 Months (Contract To Hire)
MAJOR DUTIES:
• 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 team work and good communication.
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Supports customer complaint investigation by performing inspection of retains and complaint samples
Education Requirements
Education or Experience: (Minimum required to perform job)
• Preferred - Bachelor's Degree in related science or technical field in combination with 2 years prior relevant work experience.
• Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.
• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.