Similar posts
Quality Assurance Specialist III
This vacancy has now expired. Please see similar roles below...
Proclinical are working exclusively with a leading global pharmaceutical company that specialises in in multiple therapy areas. This organisation is currently advertising a vacancy for a Quality Assurance Specialist III. This is an exciting opportunity to join this company's team in Massachusetts.
The Quality Assurance Specialist will help deliver on company commitments for patient safety, product quality, and data integrity by ensuring the quality and regulatory compliance of computerised systems and regulated data. They will provide independent oversight of computerised system validation and operational activities to confirm that computerised systems and regulated data are maintained in compliance with applicable Healthcare laws and regulations, along with company policies and procedures. The QA Specialist will also drive and sustain improvements to computerised systems and the processes for implementing and supporting them.
Job Responsibilities:
- Providing independent oversight to assure that computerised systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations, and guidelines.
- Promoting and championing support of compliance, quality, and best practice-oriented culture regarding computerised systems.
- Authorising validation deliverables produced for computerised system projects, including operational procedures, maintenance procedures, and change requests.
- Supporting the development of CS QA related procedures.
- Participating in ongoing operational management activities, including but not limited to, demand management, the Change Advisory Board, and Quality Metrics.
- Conducting audits of computerised system vendors and 3rd party software providers, including SaaS.
- Providing expertise and support during audits and inspections of the company.
- Identifying and reporting any quality or compliance concerns and taking immediate corrective action as required.
- Proactively identifying risks and issues; driving implementation of pragmatic, compliant, and quality-based solutions.
- Leading on-going initiatives and improvement projects in areas related to computerised systems and regulated data as assigned.
- Proactively identifying and sharing emerging industry standards/trends with business partners in the area of regulated computerised systems and regulated data.
- Planning, executing, and reporting on internal audits of activities, records, and processes related to regulated computerised systems and regulated data.
- Supporting the response and remediation of corrective actions and internal audits.
- Collaborating with key business partners, including IT, Vendors, Quality SMEs, and Business System Owners to ensure activities are performed in line with company procedures, regulatory requirements, and industry standards.
Skills and Requirements:
- A Bachelors' degree in Science, Business, Engineering, IT, or related discipline; alternatively, 5 years of equivalent professional experience will be considered.
- At least 6 years of experience with FDA Regulations, ICH, EMA and/or other international healthcare regulatory requirements.
- At least 4 years of experience working with IT systems and team.
- Experience making quality assurance and compliance decisions regarding software development, validation, and support.
- Demonstrable experience with all phases of software validation and infrastructure qualification.
- Demonstrable experience with all phases of System Development Lifecycles principles, processes, and procedures.
- Demonstrable experience in working as part of a 'virtual' team.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, persuasion, influence, and leadership.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Cassini on +1 215 531 5288 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-KC1
Related jobs
US$180000 - US$210000 per annum + Highly Competitive Salary
Boston, USA
Proclinical is actively seeking a Director of Statistical Programming for a global biotechnology company. This is a permanent role with the opportunity to work remotely.
Highly Competitive
Brussels, Belgium
Proclinical is seeking a Professional Services Resource Manager. This role is pivotal in allocating resources to client projects.
Highly Competitive
Brussels, België
Proclinical are representing a medium sized, global biotech who are expanding rapidly due the significant products that are coming through in our clients pipeline.
Up to US$0.00 per annum + Highly Competitive Salary
Princeton, USA
Proclinical is seeking a talented and motivated Director of CMC for a leading biotechnology company located in Princeton, NJ.
Highly Competitive
Brussels, België
Proclinical has been retained by a cutting edge, biopharmaceutical company to appoint a Global Head of Quality for their commercial manufacturing sites.
Highly Competitive
Valais, Switzerland
Proclinical is seeking an Administrative Assistant to work a 12 month contract.
Highly Competitive Salary
Miami, USA
Proclinical Staffing is seeking an Associate Director, Access & Reimbursement - Oncology to join a global pharmaceutical organization.
Up to US$20 per hour + Highly Competitive Salary
Social Circle, USA
Proclinical Staffing is seeking a Warehouse Clerk to join a global pharmaceutical organization.
Highly Competitive
Leiden, Nederland
Proclinical is seeking a Senior Clinical Scientist to join our team. This role is integral to our development organization as we prepare to start clinical development of our Axiomer pipeline.
Highly Competitive Salary
Middletown, USA
Proclinical Staffing is seeking an Operations Manager, Chemical Manufacturing to join a leading healthcare organization.