Quality Specialist II

Thermo Fisher Scientific • Rockville, MD

1d • Onsite

About The Position

Join our Clinical Trials Division (CTD) Quality team in Rockville, Maryland, and help ensure the quality and compliance of services supporting clinical trial products for a diverse portfolio of pharmaceutical and biotechnology clients. The Rockville site is not a manufacturing facility. The operation supports clinical trial product storage and repository activities, including temperature-controlled storage, shipping and receiving, with additional pharmacy and laboratory functions on site. As a Quality Specialist II, you will play a highly visible, client-facing role within the Quality organization. A significant part of your work will involve preparing for, hosting, and following through on external client audits. With client audits occurring regularly, this role is well suited to someone who can confidently represent Quality, communicate with different audiences, navigate detailed questions, and keep multiple activities moving in a fast-paced environment. When you are not supporting audits, you will perform day-to-day Quality activities including batch record review, validation protocol review, shipment label review, and quality system documentation.

Requirements

• Bachelor’s degree in a scientific, technical, quality, or related field.
• Minimum of 2 years of relevant professional experience.
• Experience participating in, supporting, or hosting client, customer, or internal audits within a regulated or quality-focused environment.
• Demonstrated ability to interact professionally and confidently with clients, auditors, and cross-functional stakeholders.
• Working knowledge of quality systems and controlled documentation in a regulated environment.
• Ability to interpret procedures, identify the appropriate subject matter expert, and coordinate accurate responses to audit questions and findings.
• Strong written communication and documentation skills, including the ability to review responses for clarity and appropriateness before client submission.
• Strong organizational skills with the ability to manage audit preparation, follow-up activities, and routine Quality responsibilities simultaneously.
• Ability to remain composed, professional, and customer-focused during challenging or demanding interactions.
• Strong follow-through and the ability to drive actions to completion across multiple departments and competing priorities.
• Proficiency with Microsoft Office and standard business systems.
• Ability to work effectively both independently and as part of a collaborative Quality team.

Nice To Haves

• Experience in pharmaceutical, biotechnology, clinical trials, life sciences, or a comparable regulated industry is preferred but is not required.
• Experience with TrackWise or a comparable electronic quality management system is preferred.
• Experience reviewing batch records, validation or qualification protocols, labels, or similar controlled quality documentation is preferred.

Responsibilities

• Prepare for and host external client audits, serving as a primary Quality representative throughout the audit.
• Partner with site operations and coordinate with subject matter experts across functions to address client questions and retrieve supporting information during audits.
• Manage post-audit observations and findings through the quality system, including opening and maintaining records in TrackWise and coordinating responses through closure.
• Drive timely follow-up with cross-functional partners responsible for audit observations or findings, reviewing responses for completeness, accuracy, and appropriate client-facing language.
• Maintain clear communication with clients and internal stakeholders throughout audit preparation, execution, and follow-up.
• Review master batch records and post-execution documentation in accordance with applicable procedures.
• Review protocols associated with qualification and validation of temperature-controlled storage equipment, including freezers.
• Review labels associated with clinical trial product shipments entering and leaving the repository.
• Support Quality oversight activities within repository and storage areas, including periodic data-integrity and surveillance activities.
• Apply established procedures and quality requirements while helping internal partners understand and appropriately execute their responsibilities.
• Balance scheduled audit responsibilities with routine Quality work while maintaining accuracy, organization, and responsiveness.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO)
• 10 paid holidays annually
• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
• Accident and life insurance
• Short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level