Quality Operations Specialist - 2nd Shift

The Quality Operations Specialist is responsible for the Quality support functions associated with the oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval and real time monitoring/approval of manufacturing activities.

Responsibilities

• 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 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.


• Assist in investigations for deviations by supporting data gathering and root cause analysis


• Enforcement of GMP Compliance.


• Support site process improvements (training, efficiency projects, implementation of CAPAs)


• Supports customer complaint investigation by performing inspection of retains and complaint samples

* SHIFT: 12:00 – 10:30pm Mon-Th (10 hrs) plus weekend OT availability, onsite in Malvern, PA

• Bachelor’s 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.


• Safe work habits


• Basic math and computer skills


• Good communication skills


• Ability to follow written and verbal instructions


• Able to work with limited supervision for routine tasks


• Excellent documentation and handwriting skills


• Proficient reading and comprehension skills


• Sound decision-making, technical and problem-solving skills