Quality Assurance Director
3 weeks ago
RPM ReSearch is seeking a highly experienced and skilled Quality Assurance Director to lead our Quality Operations Group (QOG). The ideal candidate will have at least 8 years of experience in a quality leadership position within the biological and/or pharmaceutical industry. This role requires a strong knowledge of FDA and EMA regulatory requirements, as well as GMP regulations and international guidelines.
Job Responsibilities:
- Perform tasks according to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs).
- Demonstrate knowledge of and instruct department procedures and company policies.
- Create yearly goals for the group.
- Supervise and guide internal audits of various departments/processes.
- Oversee QA Document Control activities, including processing change requests, manufacturing records, and other documents.
- Write, revise, and review standard operating procedure (SOP)-controlled forms, and related documentation.
- Responsible for determining the disposition of all finished and in-process products in compliance with all applicable regulations.
- Addresses observations or recommendations and implements corrective/preventive actions as needed.
- Oversee supplier quality program and suppliers.
- Participate in process improvement teams to offer enhanced expertise and facilitate workflow improvements.
The estimated salary for this position is $140,000 - $160,000 per year, depending on experience and qualifications. We offer a competitive benefits package, including health insurance, retirement plan, and paid time off.
-
Waltham, Massachusetts, United States Lifelancer Full timeLead a Team in Ensuring Regulatory ComplianceWe are seeking an experienced Executive Director of Quality Assurance and Compliance to lead our quality team in ensuring regulatory compliance across all aspects of our operations.About the Role:Develop and implement a comprehensive quality strategy that aligns with our commercialization goals and global...
-
Director of Quality Assurance
2 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeAbout the RoleWe are seeking a highly experienced Associate Director to provide expert guidance in ensuring the compliance of our products with relevant US, EU, and ICH regulations.
-
Quality Assurance Specialist
3 weeks ago
Waltham, Massachusetts, United States Adecco US, Inc. Full timeCompany Overview: Adecco US, Inc. is a leading provider of human resources solutions. We are currently seeking a highly skilled Quality Assurance Associate to join our team in Waltham, MA.Job Summary: As a Quality Assurance Associate, you will be responsible for reviewing and approving Master Manufacturing Records, Stability Protocols and Reports, Sampling...
-
Senior Quality Assurance Specialist
2 weeks ago
Waltham, Massachusetts, United States Pyramid Consulting Full timeOur client, a leading healthcare industry player, is seeking an experienced Senior Quality Assurance Specialist to fill this contract position. Located in Waltham, MA, this 12+ months opportunity comes with long-term potential.Job OverviewThis Senior Quality Assurance Specialist role will be responsible for reviewing and approving Master Manufacturing...
-
Senior Quality Assurance Professional
2 weeks ago
Waltham, Massachusetts, United States Integrated Resources Full timeAbout the PositionIntegrated Resources is seeking a Quality Assurance Associate II to support our operations in Waltham, MA. The successful candidate will play a critical role in ensuring the quality and integrity of our products.Key ResponsibilitiesReview and approve Analytical related documents such as Test Methods, Test Method Transfer Plans, and...
-
Senior Quality Assurance Executive
4 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeRevolutionize Cancer Treatment as a Senior Quality Assurance ExecutiveJob Title: Senior Quality Assurance ExecutiveLocation: Waltham, MA or New York CityEstimated Salary:$200,000 - $250,000 per annumAbout the RoleSyndax Pharmaceuticals is seeking an exceptional Senior Quality Assurance Executive to spearhead its commercial-stage quality organization. This...
-
Quality Assurance Associate Lead
1 month ago
Waltham, Massachusetts, United States Mindlance Full timeJob Description:We are seeking a highly skilled Quality Assurance Associate II to join our team at Mindlance. In this role, you will be responsible for ensuring the highest quality standards in our manufacturing processes.Main Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated...
-
Software Quality Assurance Engineer
3 weeks ago
Waltham, Massachusetts, United States Diverse Lynx Full timeOverviewDiverse Lynx LLC is an Equal Employment Opportunity employer. We promote and support a diverse workforce across all levels in the company.Salary and BenefitsThe estimated salary for this role is $80,000 per year. As an employee of Diverse Lynx LLC, you will receive comprehensive benefits, including health insurance, retirement plans, and paid time...
-
Biologics Quality Assurance Manager
2 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeJob Title: Biologics Quality Assurance ManagerWe are seeking a Biologics Quality Assurance Manager at Lifelancer, a talent-hiring platform in Life Sciences, Pharma, and IT.Estimated Salary: $100,000 - $160,000 per year.About the CompanyMural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may...
-
Senior Quality Assurance Professional
15 hours ago
Waltham, Massachusetts, United States Lifelancer Full timeArdelyx is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing innovative first-in-class medicines. As a Quality Assurance Specialist III, you will be part of a fast-paced pharmaceutical environment with a broad scope of responsibilities.The successful candidate will provide QA support for Quality Operations, working...
-
Quality Assurance Associate II Specialist
3 weeks ago
Waltham, Massachusetts, United States Integrated Resources Full timeJob OverviewWe are seeking a highly skilled Quality Assurance Associate II to join our team at Integrated Resources. This role is responsible for ensuring the quality and integrity of our products, from raw materials to finished goods.About the RoleThe ideal candidate will have a strong background in quality assurance, with a minimum of 5 years of experience...
-
Quality Assurance Manager
3 weeks ago
Waltham, Massachusetts, United States Pyramid Consulting Full timeWe are currently seeking a highly skilled Quality Assurance Manager to join our team on a contract basis. This 12+ months opportunity offers long-term potential and is located in Waltham, MA.About the RoleThe Quality Assurance Manager will oversee the review and approval of various documents, including Master Manufacturing Records, Stability Protocols, and...
-
Senior Quality Assurance Specialist
4 weeks ago
Waltham, Massachusetts, United States Pyramid Consulting Full timeJob SummaryWe are seeking a skilled Senior Quality Assurance Specialist to join our team. This is a contract position located in Waltham, MA.Key Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for timely GMP manufacturing activities initiation.Perform QA...
-
Senior Quality Assurance Associate
3 weeks ago
Waltham, Massachusetts, United States Mindlance Full timeJob OverviewMindlance seeks a seasoned Quality Assurance Associate to join our team. As a key member of our Quality Department, you will play a critical role in ensuring the highest standards of quality and compliance.Key Responsibilities:Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated...
-
Quality Assurance Engineer Internship
3 weeks ago
Waltham, Massachusetts, United States Dassault Systemes Full timeAbout the Opportunity:Dassault Systemes is committed to delivering high-quality software solutions, and we're seeking a talented intern to join our team as a Software QA Engineer. In this role, you'll have the chance to work closely with cross-functional teams and contribute to the development of our core simulator software.This internship offers a unique...
-
Pharmaceutical Quality Assurance Lead
14 hours ago
Waltham, Massachusetts, United States Lifelancer Full timeJob DescriptionSupport the reporting of Quality metrics on a monthly and quarterly basis in support of Management reviews and KPIs.Perform batch record review and product dispositions in support of clinical trials, registration, validation, and commercial product distribution.Maintain Continued Process Verification data collection in real-time at batch...
-
Intern Software Quality Assurance
3 weeks ago
Waltham, Massachusetts, United States Dassault Systemes Full timeAbout This Internship:We're looking for a highly motivated and detail-oriented individual to join our team as a Software QA Engineer Intern. In this role, you'll have the opportunity to work on exciting projects, develop your skills in software quality assurance, and contribute to the success of our organization.This internship is an excellent way to gain...
-
Senior Quality Assurance Manager
1 month ago
Waltham, Massachusetts, United States RPM ReSearch Full timeJob DescriptionAt RPM ReSearch, we are seeking an experienced Senior Quality Assurance Manager to lead our quality team and ensure compliance with regulatory requirements.Key Responsibilities:Develop and implement effective quality management systems that meet or exceed regulatory standards.Supervise and guide internal audits of various departments and...
-
Waltham, Massachusetts, United States Boston Children's Hospital Full timeBoston Children's Hospital is seeking a Medical Instrumentation Quality Assurance Specialist to join our team. As a key member of our Sterile Processing department, you will play a vital role in ensuring the accuracy and proper assembly of instrument trays.The ideal candidate will have 5+ years of experience in Sterile Processing and be certified in SPD,...
-
Sterile Processing Quality Assurance Specialist
14 hours ago
Waltham, Massachusetts, United States Boston Children's Hospital Full timeAbout the RoleThis is a key position within the Sterile Processing department at Boston Children's Hospital. The successful candidate will be responsible for ensuring the accuracy and proper assembly of surgical instrument trays, verifying their functionality, and adhering to internal standards.Key ResponsibilitiesKit Review and Accuracy: Maintain review...