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Quality Assurance Specialist

Company: Guidehouse
Location: Bethesda
Posted on: March 18, 2023

Job Description:

Job Description:

Job Family:Clinical Trial Operations (Digital) Travel Required:None Clearance Required:Ability to Obtain NACI What You Will Do: Review records related to the general operations of a Pharmacy clean roomProvide Quality Assurance input and oversight in aseptic processing/compounding facilities within the NIH.Provide on-the-floor QA oversight in the cleanroom and support to ensure compliance to GMP regulations and USP guidance throughout those areas.Perform quality walk-throughs and process observations.Review test methods and EM data.Ensure timely resolution and escalation of issues within the operational areas.Ensure products are compounded in compliance with USP guidelines.Ensure all product-related and facility Deviations are initiated, investigated, and resolved.Support the maintenance of the CAPA, Deviation, Environmental Excursion, Investigations, and Change Control programs.Generate and revise standard operating procedures and associated documents as needed.Identify compliance risks and escalate the issues to appropriate levels of management for resolution.Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed.Conduct vendor qualification programs to support aseptic processing/compounding facilities within the NIH.Receive, log, and release incoming supplies and material to the cleanroom.Support the maintenance of the document control system, including formatting, numbering, and scanning of records into the Document Management System (DMS).Support the maintenance of the Equipment Control and Service program, including but not limited to, on-boarding of new equipment, maintaining calibration/preventative maintenance records, updating the equipment database, and notifying the operations staff of pending calibration/preventative maintenance activities.Support the maintenance of the Internal and External Audit program, with guidance from Management.Track, analyze, and report on Quality Performance Indicators (QPIs).Participate in the training of new employees and contractors, as required.Participates in root cause analysis using methods such as Ishikawa diagrams, 5 Whys, comparative analysis, and process flow charting, as required.Identify and drive system improvements, both within Quality Assurance and for laboratory operations, to effectively accomplish the goals or strategies of the Service and to maximize quality and productivity of the Service.Independently develop, write, and lead the implementation of controlled documents (i.e. SOPs, Policies, Protocols) which may entail significant system changes.Stay current with changes to current Good Manufacturing Practices and USP Standards for compounding pharmacies.Follow established policies and procedures and apply applicable regulations based on assignment, such as GMP, CFR, and ICH regulations. What You Will Need:Bachelor's degree in Regulatory Science or related field, pharmacy degree preferred3 years of experience performing Quality Assurance functions in an FDA regulated facility (either a GMP facility or a Compounding Pharmacy)Knowledge of the FDA regulations that cover manufacturing such as USP 797, USP 800, USP 823, FDA 21CFR211 and/or FDA 21CFR212Knowledge of the ISO requirements for a quality management systemExperience authoring SOPs and trending and tracking of dataKnowledge of cGMP, aseptic processing, and Microbiology is strongly preferred but not requiredStrong communications skills, both oral and writtenExcellent analytical, organizational and time management skillsAbility to rapidly adapt to changing environment and circumstancesAbility to work effectively in a team environment What Would Be Nice To Have: What We Offer: 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 Personal and Family Sick Time & Company Paid Holidays Parental Leave 401(k) Retirement Plan Group Term Life and Travel Assistance Voluntary Life and AD&D Insurance 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 Employee Referral Program Corporate Sponsored Events & Community Outreach annual membership Employee Assistance Program 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 About GuidehouseGuidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

Keywords: Guidehouse, Bethesda , Quality Assurance Specialist, Other , Bethesda, Maryland

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