New · posted Oct 13
Thermo Fisher Scientific · Pharmaceuticals
Quality Operations Specialist
- Cincinnati, OH
- On-site
- Full-time
- Associate & Specialist
Closes Nov 12, 2026 · 30 days left
The role
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.
What you need
Education
•High School Diploma or GED with 5years of experience in a Quality role within a GMP-regulated facility or
•Bachelor’s degree with 2 years of experience in a Quality role within a GMP-regulated facility.
•Experience in pharmaceutical manufacturing, biologics, medical device, or other regulated manufacturing environments preferred.
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
- 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.
- 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
What you'll do
- 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).
Where you'll work
Cincinnati, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in Cincinnati, OHSchedule and working conditions
Days
Hours
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.)
Shift: FOWN (Front of Week Nights) Monday-Wednesday 6:00pm-6:30am
While on training for 1-3 months schedule will be Monday-Friday 8AM-5PM
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.
Job intelligence
The context around this role
Live data · October 13, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US103 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $72,000 | $84,000 | $100,750 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 642 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs11
- GMP and compliance10
- Collaboration and leadership7
- Investigations and CAPA6
- Data and digital systems3
- Quality systems and risk2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Thermo Fisher on Regulatory Jobs
- 85
- Open roles
- 71
- Distinct roles
- 35
- Locations
By discipline
- Quality77 91%
- Regulatory6 7%
- Compliance & Safety2 2%
By level
- Senior & Principal35 41%
- Associate & Specialist28 33%
- Manager16 19%
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Quality Operations Specialist at Thermo Fisher
Applications close November 12.