Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 4/1/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Quality Assurance Specialist
Industry: Medical / Biotech
Location: Milford, MA
Employment Type: Full Time, Permanent
Pay Range: 85-90K
Quality Assurance Specialist III
Looking for at least level 3 – someone who understands the terminology CAPA’s & investigations. We need someone that has led the team/investigation.
• Bachelor’s Degree in a scientific discipline, or Associate’s Degree in a scientific discipline with at least 8 years’ Quality Assurance experience in a serology, immuno-chemistry, and/or molecular biology work environment.
• A minimum of 5 years of experience working in a cGMP or ISO 13485 environment.
• Facilitate and lead cross-functional teams in investigations of deviations, nonconformances, CAPAs, and product complaints to determine root cause and implement corrective actions to mitigate root causes; work constructively with functional groups to determine root causes for process issues related to products and services.
• Ensure accurate QMS records related to non-conformances, deviations, customer complaints and CAPAs.
• Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, etc. to identify actions required.
• Track and trend of site quality system metrics. Develop action plans for negative performance.
• Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings.
• Review risk management documentation and actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce risks to acceptable levels.
• Review and approve Document Change Requests (DCRs) related to materials, production processes, and test methods.
• Support ongoing product release activities such as review of batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations.
• Accurate review and approval of records comparing results to internal and customer specifications, SOPs, and established standards for product release.
• Provide training and support for quality concepts and tools.
• Root cause analysis expertise.
• Focused on problem solving, including problem definition, risk evaluation, and risk-based resolution.
• Strong analytical and examination capabilities for complex projects; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress.
• Ability to track and complete multiple priorities in a dynamic environment.
• Supplier auditor experience desired.
• Strong interpersonal, organizational, verbal and written communication skills.
• Demonstrates curiosity, adaptability and commitment; works best in a team environment and actively seeks to foster relationships.
• Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process.
• Oriented to continuous improvement with desire to balance the level of control and flexibility in systems based on risk.
• Impeccable attention to detail.
• Ability to manage multiple tasks and meet timelines with minimal supervision.
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776