Experience Required
12 months
Minimum Education Required
Master's
License(s) Required
No
Training Required/Provided
No
Compensation
$174,720.00 - $174,720.00 / Yearly
Hours Per Week
40
Number Of Positions
1
Shift
Unspecified
Job Description
QA Lead Technical Operations (Piscataway, NJ, or other unanticipated locations throughout the U.S.). Responsibilities include: Provide Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Responsible for decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations. Review and approve Quality, Quality Control, Validation and Automation related documents. Review and approve Standard Operating Procedures (SOPs). Review and approve Validation related documentation such as risk assessments, protocols and test scripts and summary reports. Review and approve change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements. Coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation. Interpret complicated data and make sound decisions. Telecommuting permitted. M.S. in Computer Science, Information Technology, or a related field. 12 months’ experience as QA Lead, Sr. Computer Systems Validation Engineer, Validation Lead, or a similar position. 12 months’ experience in: Defect management, Risk/ Gap Assessment, authoring and owning the validation deliverables for the change management, support Change Control, deviation resolution (CAPA), Master Control – Quality Record Management System, Blue Mountain, GxP, and Data Integrity. University coursework must have included: Analyzing & Visualization Data, Information security and risk management. 40 hrs/wk. 8:00 am – 5:00 pm. $174,720/year. Medical, dental, and vision insurance. 401(k). PTO/ sick leave in accordance with applicable law and company policy. Professional development and training opportunities. Send resume & salary reqs. to Synkriom, Inc. at: hr@synkriom.com. (Ref. code QALTO). No
phone calls please. EOE.
Place of Work
Hybrid
Requisition ID
QALTO
Job Type
Full Time
Application Email
hr@synkriom.com