Quality Assurance Specialist Salary at Avecia Ltd BETA

The Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing Organizations (CMOs). Provide assistance in the audit and oversight of Contract Research Organizations (CROs) as directed. The incumbent will work closely with the Director, Quality Assurance to ensure company goals and objectives are met and compliance risks are identified and communicated to senior management. This position is located in Cambridge, MA. Key Responsibilities: Conduct and maintain New Employee Quality Orientation and Quality Refresher Training with primary responsibility for the Training System including documentation. Develop and contribute to Policies and SOPs in support of the Quality Systems Manual. Review and approve Polic

Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations. Reviews and approves Quality, Quality Control, Validation and Automation related documents Review and approve Standard Operating Procedures (SOPs). Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports. Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements. Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation. Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment. Able t

Our client, in science field, is seeking a **Quality Assurance Specialist** to join their team. The ideal candidate will have science lab, documentation and auditing/reporting skills which will align successfully in the organization. **Job Title: Lab Quality Assurance Specialist** **Location: Norwell MA (Hybrid)** **Pay Rate: $27.86** **Contract: 6 months (extension/conversion to permanent possible)** **What's the Job?** + Assists Quality Assurance management in ensuring that programs/activities are conducted in compliance with applicable regulations/standards and quality assurance plans of government agencies and company policies by performing assigned audits and inspections. + Will work with environmental scientists and database developers to review data tables that were acquired, assembled, converted and formatted for assimilation into a database. + Review data provided by company's environmental chemistry laboratory, offering ultra-trace analytical chemistry specifically establishe

***This job requires you to be onsite in Mansfield, MA or Norton, MA.*** The Quality Assurance Specialist II will provide onsite intermediate-level, hands-on support from a regulated systems perspective in a GxP laboratory services, repository, and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components. In addition, this position is responsible for managing the document and record control system. Extended work hours may be necessary in order to meet business demands. Essential functions of the job include but are not limited to: Quality Function: Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resol

Our client, in science field, is seeking a Quality Assurance Specialist to join their team. The ideal candidate will have science lab, documentation and auditing/reporting skills which will align successfully in the organization. Job Title: Lab Quality Assurance Specialist Location: Norwell MA (Hybrid) Pay Rate: $27.86 Contract: 6 months (extension/conversion to permanent possible) What's the Job? A ssists Quality Assurance management in ensuring that programs/activities are conducted in compliance with applicable regulations/standards and quality assurance plans of government agencies and company policies by performing assigned audits and inspections. Will work with environmental scientists and database developers to review data tables that were acquired, assembled, converted and formatted for assimilation into a database. Review data provided by company's environmental chemistry laboratory, offering ultra-trace analytical chemistry specifically established for supporting risk-based s

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands.We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Quality Engin

Job Details Quality Assurance Specialist Contractor Bedford, MA About Us... Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian's programs apply our cytoDRiVE platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. We're currently investigating our lead program OBX-115 and enrolling patients in an ongoing clinical trial in advanced or metastatic melanoma. We're proud of our diverse talented team and committed to cultivating an environment where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, comp

Quality Assurance Specialist II - Night Position Summary: Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is hiring a Quality Assurance Specialist II - Operations who is responsible for supporting operations in a GMP Manufacturing Facility. This individual provides oversight of production activ