Job description
Title: Quality Assurance Associate 2md Shift
Location: Lexington, MA
Shift: 2nd Shift, 3 pm to 11pm Monday through Friday
Status: 6-12 month contract
Hourly rate: $55 an hour
Quality Assurance Associate
This individual in this office-based role will maintain on site quality presence at GMP facility in Lexington, MA by providing support for clinical phase manufacturing, batch record review and quality issue resolution. Will also support incoming raw material/excipient release, document management and training systems. Primary function is to assure the quality of manufactured products is in compliance with all applicable regulations, guidelines and internal procedures.
Responsibilities:
• Proactively promote GMP, GDP, and compliance concepts.
• Support incoming raw material release.
• Support Supply Chain and Manufacturing with dispensing of raw material for batch production.
• Support QC, Analytical Research and Development (ARD) with CoA review, approval, and filing.
• Perform quality oversight of clinical phase manufacturing executional compliance with GMP, including issuance of production batch records, line clearance, QA on the floor presence, raw material, component, and in-process material checks.
• Support batch documentation review, deviations/investigations, change control and issue resolution for Intermediate and Drug Product (DP) Disposition.
• Participate in document life-cycle and training management, such as initiation, document number issuance, document revision, approvals, distributions, and review and filing of training documentation.
• Review documents for formatting, use of templates, completeness and consistency.
• Assist in building and maintaining templates for each document type.
• Provide support in maintaining employee training records and department curricula build out.
• Actively participate in the continuous improvement of quality systems.
Qualifications:
Minimum of BA/BS in a science related field
• Minimum of 5 years of related work experience in pharmaceutical, biotech or medical industry
• Knowledge of Good Manufacturing Practices (GMPs), Good Documentation Practices and application within pharmaceutical development.
• Solid computer skills using Microsoft Word, Excel, PowerPoint, SharePoint and Smartsheet.
• Good organizational, verbal, and technical written communication skills, able to execute multiple tasks.
• Good interpersonal communication skills/able to work in a team environment.
• Able to rapidly adapt to changing environment and circumstances requiring flexibility.
• Ability to troubleshoot and problem solve.
Location: Lexington, MA
Shift: 2nd Shift, 3 pm to 11pm Monday through Friday
Status: 6-12 month contract
Hourly rate: $55 an hour
Quality Assurance Associate
This individual in this office-based role will maintain on site quality presence at GMP facility in Lexington, MA by providing support for clinical phase manufacturing, batch record review and quality issue resolution. Will also support incoming raw material/excipient release, document management and training systems. Primary function is to assure the quality of manufactured products is in compliance with all applicable regulations, guidelines and internal procedures.
Responsibilities:
• Proactively promote GMP, GDP, and compliance concepts.
• Support incoming raw material release.
• Support Supply Chain and Manufacturing with dispensing of raw material for batch production.
• Support QC, Analytical Research and Development (ARD) with CoA review, approval, and filing.
• Perform quality oversight of clinical phase manufacturing executional compliance with GMP, including issuance of production batch records, line clearance, QA on the floor presence, raw material, component, and in-process material checks.
• Support batch documentation review, deviations/investigations, change control and issue resolution for Intermediate and Drug Product (DP) Disposition.
• Participate in document life-cycle and training management, such as initiation, document number issuance, document revision, approvals, distributions, and review and filing of training documentation.
• Review documents for formatting, use of templates, completeness and consistency.
• Assist in building and maintaining templates for each document type.
• Provide support in maintaining employee training records and department curricula build out.
• Actively participate in the continuous improvement of quality systems.
Qualifications:
Minimum of BA/BS in a science related field
• Minimum of 5 years of related work experience in pharmaceutical, biotech or medical industry
• Knowledge of Good Manufacturing Practices (GMPs), Good Documentation Practices and application within pharmaceutical development.
• Solid computer skills using Microsoft Word, Excel, PowerPoint, SharePoint and Smartsheet.
• Good organizational, verbal, and technical written communication skills, able to execute multiple tasks.
• Good interpersonal communication skills/able to work in a team environment.
• Able to rapidly adapt to changing environment and circumstances requiring flexibility.
• Ability to troubleshoot and problem solve.