Senior Quality Control Associate - Aditi Consulting
West Greenwich, RI
About the Job
Summary:
The Quality Control Equipment group is responsible for the end-to-end life cycle of equipment in QC. This includes procurement, development, and execution of validation and change control strategy, oversight and execution of general and preventative maintenance activities, and decommissioning support as required.
Responsibilities will include, but are not limited to:
What we are looking for:
Experience:
Preferred Qualifications:
Top 3 Must Have Skill Sets:
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
The Quality Control Equipment group is responsible for the end-to-end life cycle of equipment in QC. This includes procurement, development, and execution of validation and change control strategy, oversight and execution of general and preventative maintenance activities, and decommissioning support as required.
Responsibilities will include, but are not limited to:
- Execute routine work orders and interact routinely with end customers and vendors, ensuring reliable QC equipment support in a fast-paced environment.
- Own change controls for new and/or replacing of QC equipment.
- Manage the procurement of new QC equipment. Work autonomously to lead cross-functional stakeholders to identify end-user requirements, establish validation requirements and Change Control strategy.
- Supports inspection readiness activities across Quality Control, and site audits and inspections.
- Monitor and trouble shoot analytical benchtop equipment.
- Lead projects and project planning responsibilities to ensure on time implementation of analytical instruments. Responsible to implement projects on time and on budget.
- Complete all assigned tasks on time, in collaboration with key stakeholders.
- Provide oversight of vendor PMs.
- Create new assets and PM scheduling in Maximo.
- Obtain end user requirement and vendor quotes for lifecycle replacement of equipment.
What we are looking for:
- Experience in writing and managing Change Controls
- Experience in executing general, preventative, and corrective maintenance in Maximo system.
- Validation experience (Lab equipment, computer related systems)
- Focus on data integrity and cGMP practices
- Project management
- Proficiency in Excel, Word, and PowerPoint, Outlook, and Project
- Strong interpersonal skills
- Excellent written and verbal communication skills (including technical writing and presentations)
- Experience with analytical laboratory testing with the ability to plan and perform routine tasks with efficiency and accuracy.
- Demonstrated ability to work independently and deliver the right first-time results
- Commitment of 40-hour work week in West Greenwich, RI. This is a full-time on-site role
Experience:
- Bachelor’s degree and 2 years of Quality/ Operations Experience OR Associate's degree and 3+ years of Quality/ Operations Experience OR High school diploma/GED and 4+ years of Quality/ Operations Experience
Preferred Qualifications:
- GMP and GDP experience in a laboratory setting.
- Proficient in Track wise, Maximo, CDOCS
- Experienced in Quality systems, including Change Control, Deviations, CAPA
- Experienced in Quality processes, including validation and data integrity
- Proficient in problem solving and LEAN principles
Top 3 Must Have Skill Sets:
- Computer Skills
- Autonomy
- Teamwork
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
Source : Aditi Consulting