Quality Assurance Specialist Salary at Verocel 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

Are you passionate about ensuring quality and compliance in the pharmaceutical industry? Do you thrive in a remote work environment where you can make a difference from the comfort of your own home? If so, we have the perfect opportunity for you!As a Remote Quality Assurance Specialist at Astrazeneca, you will play a crucial role in maintaining our high standards of quality and regulatory compliance. You will work closely with our team to review and approve documents, conduct audits, and ensure that all processes and procedures meet industry standards.**Responsibilities:**- Review and approve documents to ensure compliance with regulatory requirements- Conduct audits to identify areas for improvement and ensure adherence to quality standards- Collaborate with cross-functional teams to implement quality control measures- Provide training and support to team members on quality assurance best practices- Stay up-to-date on industry regulations and best practices to ensure compliance**Requi

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

Job Posting Description General Summary The Sterile Processing Quality Assurance Specialist (QA) is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets. This role includes verifying instrument placement, checking for good working order, and preparing trays for processing. The QA specialist provides immediate feedback and coaching, documents data in provided software, and identifies discrepancies/errors in count sheets. Additionally, the QA specialist may assist in developing, recommending, and implementing educational needs, internal standards, policies, and procedures to improve the quality and effectiveness of patient care and sterile processing. Participation in hospital, departmental, and multidisciplinary programs, committees, and special projects may also be required. Values Statement The Sterile Processing Quality Assurance Specialist embodies the hospital's core values in all interactions with patients, families, and colleagues

Job Title: Quality Assurance Specialist Job Description Manage QC data of multiple programs through external/third party suppliers (CDMO, CTO, etc.). Review raw data from third-party release and stability testing, perform trending for release and stability using applicable software (JMP, iStability, etc.), and draft and review QC documentation including Stability Protocols and Reports, SOPs, Material specifications, CoA templates, and other quality documents. Collaborate with Analytical Development to support method qualification, fit for use, validation, and method transfer activities. Support the reference standard program and draft and execute quality systems (e.g., OOS/OOT, Deviations, Change Controls, and CAPAs). Additional responsibilities and ad hoc projects as required. Responsibilities + Manage QC data of multiple programs through external/third party suppliers (CDMO, CTO, etc.). + Review raw data from third-party release and stability testing. + Perform trending for release a

Our client, a leader in the pharmaceutical industry, is seeking a Pharmaceutical QA Specialist to join their team. As a QA Specialist, you will be part of the Quality Assurance department supporting various manufacturing teams. The ideal candidate will have strong communication skills, a proactive mindset, and the ability to work collaboratively, which will align successfully in the organization. Job Title: Pharmaceutical QA Specialist Location: Cambridge, MA Pay Range: $50-55 per hour What's the Job? Execute all activities following quality and regulatory standards and procedures. Provide on-the-floor support to manufacturing activities. Review manufacturing batch records for completeness and compliance with cGMPs. Ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation. Review and approve Standard Operating Procedures, logbooks and QC data. Assist in the coordination of work for the QA

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. Summary o

**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 Catalents 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