Quality Specialist III

Job Title: Quality Specialist III
Job Location: Allentown, PA
Job Duration: 12 Months+ (Temp to perm)
 
Shift Timing: Monday- Friday 8 am-5 pm
Pay rate: $40 - $45/hr. on w2.
 
Job Description:
Shift Hours: 8 am-5 pm
Potential for temp to perm dependent upon needs
Quality Specialist – Pharma Services Group/ Clinical Trial Division
 
How will you make an impact?
Reporting to the Quality Manager- Documentation in PSG supporting the Clinical Trial Division (CTD) this role is responsible for the review and release of clinical and commercial paper and electronic batch records.


What will you do?

• Adheres to the fundamentals of cGMP with a focus on patient safety and supports the rapid launch of products.
• Uses sound knowledge of regulations, authorizations, products, and processes, coupled with the experience of manufacturing and packaging, and its business requirements to thoroughly verify all aspects of the batch safety, identity, strength, purity, and quality. Collaborates with Clients to fully comprehend their Batch review and release requirements and the regulatory obligations that their company must fulfill.
• Carries out a full analysis of all inputs into the Batch creation process. Considers all factors that may affect the quality of the batch in view, such as environmental monitoring, analytical results, calibration, validation, preventative maintenance records, and investigations to include the impact of ‘split-site’ or ‘multiple-site’ processing as part of the final batch release criterion.
• Ensures product batches that have not met the prescribed in-process and finished product specifications and regulatory requirements are dispositioned to be quarantined or rejected (when applicable) to prohibit use or release.
• Interacts with Operations, Quality (QA), and internal functional units for resolution of batch release quality issues or potential quality issues.
• Proactively identifies batch review concerns, promptly communicates and raises (when appropriate) issues of batch release non-compliance, Out-of-Specification (OOS), or potential failure to Quality
• Management. Recommends steps to resolution, when appropriate.
• Prioritizes batch record reviews and Client releases to achieve objectives and deliver industry quality results within a short and long-term operational focus with mentorship from the Production Schedule, Client Services, and Quality Management.
• Maintains both internal and external customer service expectations with clear, concise, and expedited communication.
• Communicates delays promptly to affected internal parties.
• Ensures the above-mentioned provisions, including the cumulative processing impact are analyzed, and are satisfied before the finished goods batch is certified to be placed on the market.
• Represents QA and provides support to internal team meetings, as needed.

 
Required Experience

• Bachelor's Degree is required (Life Science preferred); advanced degree is a plus
• 3-5 years of pharmaceutical or medical device experience in a GMP environment, preferably in Quality. With 3 years of finished goods commercial batch release experience strongly preferred.
• Must be detail-minded detecting errors or deficiencies on batch records with the ability to use good judgment in discerning if documentation accurately and completely reflects packaging operations.
• Ability to communicate openly and effectively in an engaging manner with colleagues of various levels of experience and management.
• Experience with Quality Systems (change control, deviations, complaint management, eDMS), with a desired knowledge of SAP, Trackwise, and Documentum.