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Quality Control Senior Associate
Job Description
*Depending on experience
Full time onsite - 8-5 (Flexible)
Open to a recent graduate or someone with 0-2 years of related experience.
Must Have: Baseline industry knowledge in Pharma. Possibly a candidate who took relevant coursework in college.
Nice to have: Testing or lab experience around analytical instruments in quality control testing.
QC Senior Associate:
The Rhode Island 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.
This position is a full time on-site position at ARI (West Greenwich, RI location)
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 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
o OR
• High school diploma/GED and 4+ years of Quality/ Operations Experience
Preferred Qualifications
• GMP and GDP experience in a laboratory setting.
• Proficient in Trackwise, 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
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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