Quality Operations Specialist - 2nd Shift
Job Type :
Required Years of Experience :
Required Education :
Job Industry :
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