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Xavier University
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Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off, Designated Paid Holidays, Retirement Savings Plan
Posted 53d ago
~36 hrs/week
Responsibilities
The specialist serves as the senior QA point of contact for RAPID events, authoring scientifically sound deviation reports and ensuring regulatory compliance. They perform in-process QA checks, manage change control activities, and conduct annual Fit & Finish audits of manufacturing rooms.
Requirements
Requires a Bachelor's degree in Life Sciences, Chemistry, Biology, or Engineering with 3-5 years of experience in pharmaceutical or regulated manufacturing. Candidates must have strong knowledge of cGMP and FDA/EMA expectations and the ability to work 12-hour night shifts.
Full job description
Work Schedule
12 hr shift/nights
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Warehouse
Job Description
Job Description
Division / Site Specific Information
With the support of over 800 talented employees, Thermo Fisher Scientific’s Oral Solid Dose (OSD) site in Cincinnati, Ohio provides comprehensive drug development and commercial manufacturing services. The site specializes in advanced dosage forms including controlled and sustained release products, osmotic release dosage forms (laser drilling), liquid-filled hard capsules, controlled substances, and abuse-deterrent technologies.
Discover Impactful Work
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure the highest quality standards across our operations, supporting our Mission to enable our customers to make the world healthier, cleaner, and safer. As a Quality-on-the-Floor Specialist, you will collaborate cross-functionally to strengthen quality systems, drive continuous improvement, and ensure regulatory compliance in a highly regulated pharmaceutical manufacturing environment.
Shift : End of Week Night (EOWN) – Thursday-Saturday 6:00PM-6:30AM
While on training for 1-3 months schedule will be Monday-Friday 8AM-5PM
A Day in the Life
Serve as Senior QA point of contact for Quality RAPID events, facilitating path-forward and disposition determination, immediate containment actions, and ensuring sufficient data is collected to support complete and accurate deviation report generation at the conclusion of the RAPID.
Author clear, thorough, and scientifically sound deviation reports.
Partner with QA Management, Operations, Technical Services, Engineering, and other SMEs to ensure investigation conclusions are robust, well-supported, and aligned with GMP expectations.
Collaborate with Client QA to review deviation report feedback, resolve comments, and ensure final reports meet site, client, and regulatory expectations.
Track deviation report progress through review, comment resolution, approval, and closure, proactively escalating barriers, overdue actions, or alignment concerns to support timely and compliant investigation completion.
Perform in-process QA checks prior to batch initiation for each manufacturing sub-phase, cleaning & swab verification, equipment functionality, operator training, and GMP documentation checks, ensuring errors are resolved before production start and coaching Operations personnel along the way.
Support Change Control activities by creating, reviewing, and/or managing required batch record insert-pages in accordance with approved procedures.
Perform manufacturing barrier checks including installation and removal verification.
Support hold tag creation and removal activities (on raw material, product, room, or equipment) and perform associated SAP status changes to ensure accurate product and material control.
Provide consultation and guidance for process comments to ensure quality impact is appropriately assessed and documented.
Serve as QA representative for Quality RAPID events, supporting path-forward/disposition determination, immediate containment, and ensuring all quality considerations are appropriately addressed.
Perform Fit & Finish audits of Manufacturing on an annual basis per FDA requirement to ensure all GMP rooms are inspected and observations are tracked and actioned by support groups.
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shift work (as required).
Keys to Success
Education
Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or a related field (or equivalent experience).
3–5 years of experience in pharmaceutical manufacturing, biologics, or regulated manufacturing environments.
Experience
Experience in quality assurance or operations within GMP environment (pharmaceutical, biotech, or medical device preferred)
Experience with batch record review preferred.
Familiarity with SAP or other ERP systems preferred.
Knowledge, Skills, and Abilities
Knowledge
Strong working knowledge of cGMP, GDP, and FDA/EMA regulatory expectations.
Understanding of pharmaceutical manufacturing processes and cleanroom operations.
Familiarity with batch record documentation and data integrity principles.
Skills
Strong attention to detail and documentation accuracy
Effective communication and on-the-floor coaching ability
Ability to identify compliance gaps and drive immediate corrective actions
Organizational and time-management skills
Strong verbal and written communication skills
Strong interpersonal skills with the ability to collaborate across functions and levels
Abilities
Problem-solving and root cause analysis capabilities
Ability to make sound quality decisions in real time
Ability to work effectively in controlled manufacturing environments
Ability to balance compliance requirements with operational efficiency
Ability to collaborate cross-functionally and escalate issues appropriately
Ability to work independently to consistently meet daily and weekly expectations
Physical Requirements / Work Environment
Workstation is located in pharmaceutical manufacturing environment
Ability to stand and walk for 10 hours or more per day
Ability to wear appropriate personal protective equipment (PPE) as required
Benefits
Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan, and comprehensive benefits starting Day 1, including:
Medical, Dental, and Vision Insurance
Paid Time Off and Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Relocation assistance is not provided.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, including a drug screening.
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development opportunities. Our culture is built on integrity, intensity, involvement, and innovation.
Related keywords
cGMPGDPFDAEMAPharmaceutical ManufacturingCleanroomSAPERPDeviation ReportsBatch RecordsQuality AssuranceChange ControlRoot Cause AnalysisPPEOral Solid DoseOSD
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care