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Quality Operations Specialist - 2nd Shift

Location : Malvern, PA
Job Type : Internal Direct
Hours : Full Time
Required Years of Experience : 2-4
Required Education : Bachelor's preferred
Travel : No
Relocation : No
Job Industry : Manufacturing
Job Category : Pharmaceutical Operational Support

Job Description :

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.



  • 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

Required Qualifications :

* 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

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