Guidehouse
Management Analyst
US - MD, Bethesda · Full-time
No sponsorship$56k-$94kDetected 1 day ago
ProcurementControlsGMPFDA RegulatoryResearchCommunicationTime ManagementMicrosoft Office
About the role
- The annual salary range for this position is $56,000.00-$94,000.00.
- All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com.
- Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.
Responsibilities
- Provide comprehensive administrative, analytical, and operational support to the NCI/CCR TIL Lab ensuring efficient day-to-day operations within a cGMP-regulated environment.
- Coordinate and maintain document control systems, including SOPs, training records, batch records, calibration records, and regulatory documentation to ensure GMP compliance.
- Serve as liaison across clinical, laboratory, regulatory, and cGMP teams to support communication, workflow coordination, and document management.
- Manage document management systems, ensuring version control and accuracy of critical manufacturing and compliance documents.
- Maintain and develop databases tracking training, SOPs, batch records, equipment maintenance, and compliance activities.
- Support clinical and lab operations by coordinating production schedules, material availability, and time-sensitive processes related to cell therapy manufacturing.
- Provide administrative support including document conversion, intranet updates, manuscript tracking, and executive-level correspondence review.
- Ability to manage multiple priorities in a fast-paced, compliance-driven environment.
- Knowledge of document management systems and database tracking for compliance-driven environments.
Requirements
- Ability to Obtain Public Trust
- Support audits (internal/external) by preparing, compiling, reviewing, and summarizing required documentation and findings.
- Proficiency in Microsoft Office applications.
Nice to have
- Familiarity with cGMP compliance, regulatory documentation, and clinical or laboratory operations.
- Experience supporting audits, FDA documentation, or regulatory submissions.
- Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
- Personal and Family Sick Time & Company Paid Holidays
- Group Term Life and Travel Assistance
- Voluntary Life and AD&D Insurance
- Employee Referral Program
Compensation
- Gather, analyze, and report on program data; prepare reports, correspondence, audit documentation, FDA annual reports, and materials for site visits and reviews.
- Care.com annual membership
Benefits
- Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
- Benefits include:
- Medical, Rx, Dental & Vision Insurance
- Parental Leave
- 401(k) Retirement Plan
- Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
- Transit and Parking Commuter Benefits
- Short-Term & Long-Term Disability
- Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
- Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
- Position may be eligible for a discretionary variable incentive bonus
Company info
- We are seeking a Management Analyst to independently provide support services to satisfy the overall operational objectives of the National Cancer Institute (NCI), Center for Cancer Research (CCR).
Equal opportunity
- Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
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This listing is sourced directly from Guidehouse's careers page and normalized into a canonical job model.