RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
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 for completeness, documentation, calculation errors and conformance to critical process parameters
Perform room and equipment clearances per procedure following cleaning conducted by production.
Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to manufacturing.
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.
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
Essential Skills and Experience:
Education or Experience:
Bachelors Degree in related science or technical field preferred with 2 years prior work experience
Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
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Last updated on Jan 13, 2023