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Operational Quality Senior Specialist
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Job Description
The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.
Key Duties and Responsibilities:
•Reviews executed batch records and provides customer approval for quality tasks for externally manufactured products
•Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures
•Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
•Support the day to day management of the batch release process.
•Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.
•Communicates proactively with internal and external partners and management.
•Maintains files such that documents are readily available and easily retrievable.
•Assists department with monthly/quarterly Quality System data review metrics and reporting
•Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.
Education and Experience:
•Bachelor’s degree in a scientific or allied health field or the equivalent combination of education and experience
•Experience providing QA support and oversight of GMP manufacturing operation
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
•Experience with network-based applications such as Oracle, TrackWise, Veeva
•Knowledge of current industry trends and ability to use the latest technologies
Required Knowledge/Skills:
•Strong communication and influencing skills
•Critical Thinking / Problem Solving
•Ability to evaluate quality matters and make decisions utilizing risk based approach
•Proficiency in using Microsoft Office applications
•Some experience with, Cell and/or Gene Therapy QA experience, working knowledge of aseptic processing, and quality metrics, dashboards, analysis and improvement programs
•Some experience providing QA support and oversight of GMP manufacturing operation
•Some experience successfully participating in event investigations, Root Cause Analysis and CAPA
•Some experience with network based applications such as Oracle, TrackWise, Veeva
•Basic knowledge of current industry trends and has the ability to use the latest technologies
Pay ranges between $68-74/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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