What are the responsibilities and job description for the QMS AND REPORTING SPECIALIST position at Planet Pharma?
QMS and Reporting Specialist
Location: Cambridge, Massachusetts
Category: Quality and Compliance
Salary: Apply for details
Country: United States
Employment: Contract
Worksite: On-Site
Apply For This Position
Job Description
Position Overview
The QMS and Reporting Support Contractor position within AIQ will serve as an enabler of multiple QMS initiatives, as well as support reporting and data analysis deliverables. This individual will report into the QMS and Reporting pillar of AIQ and partner with various GxP stakeholders who provide data input and deviation record ownership.
Key Responsibilities
– Bachelor’s degree in related field
– Experience with electronic Learning Management Systems and Document Management Systems
– Experience with change management and organizational development
Key Competencies
– Strong process thinking and analytical skills
– Strong experience in Excel
– Excellence in project management and organization
– Strong communication and facilitation skills
– Ability to influence without direct authority and self-starter
– Strong technical writing skills
– Demonstrated ability to leverage AI-enabled tools while ensuring GxP compliance and data integrity principles
Pay ranges between $41-51hr based 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.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Location: Cambridge, Massachusetts
Category: Quality and Compliance
Salary: Apply for details
Country: United States
Employment: Contract
Worksite: On-Site
Apply For This Position
Job Description
Position Overview
The QMS and Reporting Support Contractor position within AIQ will serve as an enabler of multiple QMS initiatives, as well as support reporting and data analysis deliverables. This individual will report into the QMS and Reporting pillar of AIQ and partner with various GxP stakeholders who provide data input and deviation record ownership.
Key Responsibilities
- Deviation Training Program & Support Model Execution
- Support implementation of a deviation investigator training pilot program, incorporating adult learning principles and hands-on application.
- Develop training materials (case studies, templates, guidance tools) to improve investigation quality and consistency.
- Partner with QA and deviation owners to establish a sustainable support model (office hours, coaching, knowledge resources).
- Analyze training program effectiveness metrics (e.g., quality of investigations, cycle times, rework trends) to inform program improvements and scalability.
- Quality Metrics, Scorecard & KPI Enhancement
- Support execution and delivery of Quality scorecards, dashboards, and KPI frameworks.
- Perform data aggregation, trending, and root-cause-oriented analysis across deviations, CAPAs, and change controls.
- Support routine and ad hoc reporting requests for Quality Management Review and Quality Systems forums, ensuring data accuracy and consistency.
- Provide project management support across QMS initiatives (timelines, deliverables, stakeholder follow-ups).
- QMS Process Support & Technology Enablement
- Assist with process mapping, gap assessments, and continuous improvement initiatives across QMS processes.
- Support data governance and data clean-up initiatives within the QMS.
- Leverage approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy.
- Bachelor’s degree in Life Sciences, Engineering, or related discipline.
- ~ 3-5 years of experience in GxP Quality Systems, QA operations, or QMS program support.
- Strong understanding of GMP, GLP, GCP regulations and ICH guidelines
- Demonstrated experience with:
- Quality Management System processes
- Quality metrics, dashboards, and KPI development
- Data analysis and trending (Excel, Power BI, or equivalent tools)
- Electronic quality management systems (Veeva strongly preferred)
– Bachelor’s degree in related field
– Experience with electronic Learning Management Systems and Document Management Systems
– Experience with change management and organizational development
Key Competencies
– Strong process thinking and analytical skills
– Strong experience in Excel
– Excellence in project management and organization
– Strong communication and facilitation skills
– Ability to influence without direct authority and self-starter
– Strong technical writing skills
– Demonstrated ability to leverage AI-enabled tools while ensuring GxP compliance and data integrity principles
Pay ranges between $41-51hr based 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.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary : $41 - $51