Quality Operations Specialist

Work Schedule

Environmental Conditions

Job Description

Division / Site Specific Information

With the support of over 800 talented employees Thermo Fisher ScientificsOral Solid Dose (OSD) site in Cincinnati Ohioprovides 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 youll discover meaningful work that makes a positive impact on a global 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 aQuality-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).

Education

• Bachelors degree in Life Sciences Chemistry Biology Engineering or a related field (or equivalent experience).
• 35 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

• 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

• 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

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

Equivalent combinations of education training and meaningful work experience may be considered.

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.