QA Specialist - Boston MA - 14803
Boston , MA 02210
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Title: QA Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 6 mos, possibility to extend
- Pay rate: $28-40/hr
- Job Location: Boston MA
- Job#: bh14219
The Operational Area Quality Specialist will provide QA support of analytical laboratory operations. This role will review data clinical and commercial analytical, release and stability data, including deviations, in-process data, and other quality systems documentation as needed in support of product disposition.
Key Duties and Responsibilities:
• Performs analytical data review for commercial release and stability and verify documentation and determines acceptability by using standard operating procedures.
• Perform quality review/ approve of raw data and COAs in support of commercial batch release when needed.
• Upload the vendor created protocols in QDocs and update all commercial stability-controlled documents in QDoccs including Vendors Stability Protocols, Initiation Forms, and Data Tables. In addition, update JMP files for all commercial products if needed.
• Provide support to Clinical analytical data review as needed
• Support the day-to-day management of the analytical data from external CMO – Update trackers in a timely manner upon receipt of data from external vendors and follow up for any major delays or issues.
• Communicates proactively with internal and external partners and management.
• Assists department mgmt. with monthly/quarterly Quality System data review metrics and reporting
• Escalate critical and major finding to Quality management related to GXP Operational areas.
Knowledge and Skills:
• Strong communication and influencing skills
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Proficiency in using Microsoft Office applications
• Some experience with quality metrics, dashboards, analysis, and improvement programs
• Some experience with network-based applications such as Oracle, TrackWise, Veeva
• Basic knowledge of current industry trends and could use the latest technologies
Education and Experience:
• Bachelor's degree in relevant field is required
• Typically requires 3-4 years of experience or the equivalent combination of education and experience
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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