Summary
Our client, a Fortune 500 Medical Device Company , has engaged GForce Life Sciences to provide a Visual Inspection consultant.
We are currently seeking an experienced Visual Inspection Consultant to join our to address and resolve AQL (Acceptable Quality Level) failures.
Project Overview
The Visual Inspection SME will play a crucial role in ensuring the quality, compliance, and accuracy of the visual inspection processes in accordance with industry standards and regulatory requirements at the site level.
They will be responsible for developing and implementing inspection standards, training personnel, and providing expertise in visual inspection methodologies.
Key Responsibilities :
- Conduct thorough visual inspections of drug products to identify defects and non-conformities.
- Analyze the root causes of AQL failures and provide actionable recommendations for corrective actions.
- To develop and implement visual inspection standards and procedures specific to medical devices and pharmaceutical products.
- Train and mentor quality assurance personnel on best practices for visual inspection.
- Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to ensure comprehensive resolution of quality issues.
- Document findings, recommendations, and corrective actions in detailed reports.
- Provide ongoing support and expertise to the quality assurance team throughout the duration of the contract.
- Provide technical guidance and training to personnel involved in visual inspection activities.
- Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, USP790 / 1790) and internal quality standards through audits and assessments.
- Support regulatory inspections and audits related to visual inspection processes.
Qualifications
- Bachelor's degree in a relevant field (e.g., Pharmaceutical Sciences, Engineering, Quality Assurance).
- Minimum of 10 years of experience in visual inspection within the pharmaceutical industry.
- In-depth knowledge of AQL standards and practices.
- Proven track record of identifying and resolving quality issues in drug products.
- Proven experience as a visual inspection SME within pharmaceutical industries.
- In-depth knowledge of regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, USP790 / 1790) and industry standards related to visual inspection.
- Proven ability to develop and implement visual inspection procedures in a regulated environment.
- Strong analytical, problem-solving, and communication skills.
Term & Start
Duration : 1 month with the opportunity to extend as needed
Start date ASAP
Onsite fully in Braintree, MA
Full time (40 hours / week)
Visual Inspection Consultant
The Visual Inspection SME will play a crucial role in ensuring the quality, compliance, and accuracy of the visual inspection processes in accordance with industry standards and regulatory requirements at the site level. We are currently seeking an experienced Visual Inspection Consultant to join ou...
Quality Control Inspector II
The QC Inspector I report directly to the QC Inspector Lead, QA Manager or Director. This position is responsible to actively participate in the Repligen ISO 13485 Quality Management System. Able to access and interpret engineering drawings, specifications, purchase orders, statement of work and sta...
Project Manager
This person will report to the Senior Project Manager (SPM) and the Director of Project Management. Onboard new projects with the Senior Project Manager and Property Management Team. Work closely with Senior Project Manager to prepare bid packages for projects. CHARLESGATE seeks a dynamic Project Ma...
Material Handler - 1st Shift
The Material Handler oversees, coordinates, and evaluates the production activities within the production plant or assigned cells. Manage the movement of materials from the receiving dock to appropriate storage location and deliver materials to production areas. EMI shielding, thermal interface mate...
Quality Inspector
Quality Inspector – Finished Goods. ...
Quality Engineer
The Ultra Assurance function is responsible for ensuring the effectiveness and fulfilment of Ultra's Quality Policy, which is to comply fully in the conduct of the This position requires an individual ready to assume responsibilities as a lead Quality Assurance Engineer. The Quality Assurance Engine...
Senior Quality Engineer
Bright Horizons is a leading education and care company, trusted by families and employers around the world for high-quality child care and early education, back-up care, and workplace education. Improve test coverage and provide quality deliverables. ...
Quality Inspector III - 2nd Shift
A Day in the LifeThe Quality Inspector will perform incoming inspections, using drawings and specifications in order to follow inspection procedure. Quality inspector will also be responsible for generating non-conforming reports on product. May monitor and verify quality in accordance with statisti...
Sterile Processing Quality Assurance Technician (11p-7:30a)
The Sterile Processing Quality Assurance Specialist (QA) is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets. Additionally, the QA specialist may assist in developing, recommending, and implementing educational needs, internal standards, policies...
Project Manager, Operations Engineering
Project Manager, Operations Engineering. Manages engineering support projects for water and wastewater operations activities, including implementing operational changes that have service impact, supporting emergency response, supporting maintenance planning, supporting in-house design and constructi...