Current jobs related to Supervisor, Quality Assurance Compliance - Westborough - Astellas Pharma
-
Quality Assurance Professional
2 months ago
Westborough, Massachusetts, United States Belcan Full timeJob Summary: We are seeking a highly skilled Quality Assurance Investigator to join our team at Belcan. As a Quality Assurance Investigator, you will be responsible for executing the triage, investigation, and closure of product quality complaints.Key Responsibilities:Execute the triage, investigation, and closure of product quality complaints.Run trend...
-
Quality Assurance Specialist
1 week ago
Westborough, Massachusetts, United States Katalyst Healthcares and Life Sciences Full timeKatalyst Healthcares and Life Sciences is seeking a highly skilled Quality Investigator to join our team. The successful candidate will be responsible for investigating customer complaints and product issues, as well as providing data and analysis to support quality improvement initiatives. Responsibilities: * Interface with customers and internal...
-
Quality Assurance Specialist
2 weeks ago
Westborough, Massachusetts, United States Coghlin Companies Inc Full timeJob Title: Quality Assurance SpecialistColumbia Tech is seeking a highly motivated and experienced Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring that our products meet the highest standards of quality and compliance.Key Responsibilities:Lead by example and promote the importance of...
-
Quality Assurance Specialist
1 week ago
Westborough, Massachusetts, United States Astellas Pharma Full timeJob SummaryAstellas Pharma Inc. is seeking a Quality Assurance Specialist to join their team at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.The successful candidate will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization.This role will...
-
Quality Assurance Specialist
2 weeks ago
Westborough, Massachusetts, United States Astellas Pharma Full timeAstellas Institute for Regenerative Medicine (AIRM) Job OpportunityWe are seeking a highly skilled Quality Assurance Compliance Specialist to join our team at Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA.About the RoleThis is an exciting opportunity to work in a dynamic and innovative environment, contributing to the development and...
-
Senior Quality Assurance Inspector
4 days ago
Westborough, Massachusetts, United States NEO Tech Full timeJob Summary:We are seeking a highly skilled Senior Quality Assurance Inspector to join our team at NEO Tech. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards are met in our manufacturing process.Key Responsibilities:Conduct thorough inspections of products throughout the manufacturing process...
-
Quality Assurance Specialist
4 weeks ago
Westborough, Massachusetts, United States Coghlin Companies Full timeJob Title: Quality Assurance SpecialistColumbia Tech is a leading provider of Time to Market Services, offering product development, manufacturing, global fulfillment, and aftermarket services to innovation leaders in various industries. As a Quality Assurance Specialist, you will play a critical role in ensuring the highest quality standards are met for our...
-
Quality Assurance Site Leader Position
4 weeks ago
Westborough, Massachusetts, United States Astellas Pharma Full timeJob DescriptionAstellas Pharma Inc. is a pharmaceutical company with a strong commitment to innovation and quality. We are seeking a highly skilled and experienced Quality Assurance Site Leader to join our team at our Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.Key Responsibilities:Develop and implement quality strategies and...
-
Quality Assurance Engineer
4 weeks ago
Westborough, Massachusetts, United States Park Place Technologies Full timeJob Title: Quality Assurance EngineerPark Place Technologies is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our software solutions.Key Responsibilities:Develop and execute test plans to ensure the quality of our software solutions.Identify and...
-
IT Quality Assurance Specialist
3 days ago
Westborough, Massachusetts, United States Connection Full timeJob Summary:Connection Services is seeking a skilled IT Quality Assurance Specialist to support our Technical Services division in Westborough, MA. The ideal candidate will have a strong background in quality assurance and testing, with experience in building test cases and working with cross-functional teams.Key Responsibilities: Develop and execute test...
-
Quality Assurance Specialist
4 weeks ago
Westborough, Massachusetts, United States Coghlin Companies Full timeJob Title: Quality Engineer IIColumbia Tech is a leading provider of Time to Market Services, offering product development, manufacturing, global fulfillment, and aftermarket services. Our clients include innovation leaders in various industries, including life sciences, alternative energy, and robotics.We are seeking a Quality Engineer II to join our team....
-
Quality Assurance Investigator
2 weeks ago
Westborough, Massachusetts, United States Belcan Full timeJob Title: Quality Assurance InvestigatorBelcan is seeking a highly skilled Quality Assurance Investigator to join our team. As a Quality Assurance Investigator, you will be responsible for executing the triage, investigation, and closure of product quality complaints.Key Responsibilities:Execute the triage, investigation, and closure of product quality...
-
IT Quality Assurance Specialist
4 weeks ago
Westborough, Massachusetts, United States Connection Full timeOverviewConnection Services is seeking a skilled IT Quality Assurance Analyst to join our Technical Services division in Westborough, MA. The IT Quality Assurance Analyst will support Application Management and Technology services efforts within the IT department, ensuring the quality and reliability of our software releases.ResponsibilitiesDevelop and...
-
Quality Assurance Investigator
1 month ago
Westborough, Massachusetts, United States Belcan Full timeJob Title: Quality Assurance InvestigatorBelcan is seeking a skilled Quality Assurance Investigator to join our team. As a Quality Assurance Investigator, you will be responsible for executing the triage, investigation, and closure of product quality complaints.Key Responsibilities:Execute the triage, investigation, and closure of product quality...
-
Quality Assurance Investigator
3 weeks ago
Westborough, Massachusetts, United States Belcan Full timeJob Title: Quality Assurance InvestigatorBelcan is seeking a Quality Assurance Investigator to join our team. As a Quality Assurance Investigator, you will be responsible for executing the triage, investigation, and closure of product quality complaints.Key Responsibilities:Execute the triage, investigation, and closure of product quality complaints.Run...
-
Quality Assurance Investigator
4 weeks ago
Westborough, Massachusetts, United States Belcan Full timeJob Title: Quality Assurance InvestigatorBelcan is seeking a highly skilled Quality Assurance Investigator to join our team. As a Quality Assurance Investigator, you will be responsible for executing the triage, investigation, and closure of product quality complaints.Key Responsibilities:Execute the triage, investigation, and closure of product quality...
-
Quality Assurance Specialist III
2 days ago
Westborough, Massachusetts, United States NEO Tech Full timeJob Summary:We are seeking a highly skilled Final Quality Inspector III to join our team at NEO Tech. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards are met in our manufacturing process.Key Responsibilities:Conduct thorough inspections of products throughout the manufacturing process to...
-
Senior Quality Assurance Inspector
2 weeks ago
Westborough, Massachusetts, United States NEO Tech Full timeJob SummaryWe are seeking a highly skilled Final Quality Inspector III to join our team at NEO Tech. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality in our products.Key ResponsibilitiesConduct thorough inspections of products throughout the manufacturing process to ensure compliance with...
-
Westborough, Massachusetts, United States Amazon Full timeJob Title: Quality Assurance Engineer, MechatronicsWe are seeking an exceptional Quality Assurance Engineer, Mechatronics to join our team at Amazon. As a key member of our Quality Management System (QMS) team, you will be responsible for defining, managing, implementing, and maintaining QMS methodologies, tools, and procedures to ensure the execution of QA...
-
Software Quality Assurance Engineer
4 weeks ago
Westborough, Massachusetts, United States LG Energy Solution Michigan, Inc. Full timeJob Title: Software Quality Assurance EngineerLG Energy Solution Michigan, Inc. is seeking a skilled Software Quality Assurance Engineer to join our team. As a Software Quality Assurance Engineer, you will be responsible for ensuring the quality and reliability of our software products.Key Responsibilities:Design, develop, and maintain testing strategies and...
Supervisor, Quality Assurance Compliance
3 months ago
**Supervisor, Quality Assurance Compliance**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Supervisor, Quality Assurance Compliance** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**
**Purpose:**
The Supervisor, Quality Assurance Compliance role oversees and performs critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients.
**Essential Job Responsibilities:**
Essential Duties and Responsibilities include, but are not limited to, the following:
+ Manages and grows the QA Compliance team responsible for QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records.
+ Collaborates with cross-functional stakeholders regarding quality events (e.g., deviations, Corrective / Preventative Actions (CAPAs), etc.), assisting in investigations and ensuring quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.
+ Serves as a resource fluent in GMP Self-Inspection / Internal Audits for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.
+ Oversees contract manufacturing organizations (CMOs), monitoring information requests, reviewing CMO work, and following up on compliance-related items.
+ Develops compliant Quality processes and procedures to satisfy new compliance requirements and leads improvement of existing work practices.
+ Participates in strategic initiatives related to new projects and initiatives, as needed.
+ Aggregates monthly metrics, identifying, planning, and executing continuous improvement opportunities for process efficiencies and compliance improvements to benefit department operations and / or the organization at large.
+ Ensures cGMP compliance through direct oversight and education of subordinate team members.
+ Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff, as appropriate.
**Qualifications Required:**
+ BS/BA, or equivalent, in Life Sciences, Engineering, or Chemistry with 7+ years of related Quality Assurance experience within GMP-regulated industry, or 5+ years with Master's degree. In lieu of a Life Sciences, or equivalent, degree, consideration will be given to candidates with minimum of 10+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
+ Previous experience in a Supervisory or Lead position.
+ Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.
+ Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.
+ Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.
+ Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).
**Preferred:**
+ QA experience supporting biologics, cell therapy, and/or gene therapy.
+ Specialized knowledge of industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
+ Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.
+ ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)
**Working Conditions:**
+ This position is based in Westborough, MA and will require on-site work. Hybrid work from certain locations may be permitted in accordance with Astellas Responsible Flexibility Guidelines.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Category BioPharma QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
