External QC Testing Specialist

Lexington, MA

Posted: 05/14/2019 Employment Type: Contract Industry: Life Sciences Job Number: 229348

 
External QC Testing Specialist
Duration: 6-12 Months 
Location: Cambridge, Massachusetts 

Top 3 Technical Skills:
1. Experience working in a QC environment with a contract testing lab (CTL)
2. Reviewing and testing protocols by CTL's for GMP production lots and ensure those protocols are compliant  
3. Support sample management activities - experience with Excel to log and update sample data

Desired Skill:
• Experience reviewing and analyzing contract testing lab protocols  

Responsibilities:
• Review/analyze testing protocols generated by CTLs for cGMP production lots including engineering and clinical lots and associated cell and viral banks.  Submit documentation for QA review.  Communicate these activities to BB clients and Management as needed.  Ensure that these activities meet project and production objectives on time.  50%

• Develop, execute and ensure compliance to outsourced testing procedures.  Review deviations/ investigations from CTLs; prepare tandem in-house investigation/ deviation reports. Assist in developing metric parameters to evaluate and monitor performance of CTLs.  25% 

• Manage outsourced testing needs, timelines, risk mitigation and business priorities.  Assist in the performance of quality audits of CTLs for compliance. Work closely with staff responsible for preparation and shipment of samples to CTLs to ensure timelines are met and samples are maintained in the appropriate condition. Communicate these activities to BB Clients and Management as needed. Ensure that these activities meet project and production objectives on time.  20%

• Other duties as assigned.  5%
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