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Quality Engineering and Validation Consultant
50 Northern Ave Boston, MA 02210 US
Job Description
Duration: 6 months (possible extension) Local candidates preferred – onsite in Boston, Monday–Friday ----------------------------------------------------------------------------------------------
The Quality Engineering and Validation Consultant is recognized as an expert internally in the principles and application of quality assurance and compliance. This position coordinates GMP activities in support of clinical and commercial Drug Product manufacture. This position reports to Associate Director GMP Quality - Cell & Gene. This is an onsite Monday through Friday position.
REQUIRED EXPERIENCE:
- Experience providing QA support and oversight of GMP manufacturing operations and capital projects
- Aseptic processing
- Experience successfully leading event investigations, Root Cause Analysis and CAPA
- Experience with network-based applications such as Veeva, Nuvolo, Viewlinc
- Master’s degree with 3-5 years of relevant work experience, or bachelor’s degree in engineering, scientific or allied health field with minimum 8 years of relevant work experience, or relevant comparable background.
REQUIRED SKILLS:
Leadership Skills
- Collaboration / Teamwork / Conflict Management
- The ability to thrive in a high throughput environment
- Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues.
- Ability to independently collaborate on cross-functional teams and represent the Quality unit
- Ability to communicate effectively across all organizational levels
- Ability to evaluate quality matters and make decisions utilizing risk-based approach
KEY RESPONSIBILITIES:
- As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Cell and Gene Therapy operations and capital projects in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of validation, analytical laboratory, materials management, and facility/engineering groups.
- Provide QA support of change controls, validation protocols, risk assessments, GMP investigations and CAPAs.
- Responsible for identifying risks and communicating gaps for GMP process/systems
- Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
- Review and approval of trending programs (equipment, facility, utilities, etc.)
- Support EM and Routine testing of facilities and utilities and control programs (BMS/EMS, pest control, etc.)
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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