Quality Assurance Specialist

Job Family:

Travel Required:

Clearance Required:

We are currently searching for a QA Specialist to provide support to the National Institutes of Health (NIH) Department of Laboratory Medicine (DLM). This is a full-time opportunity based in Bethesda MD.

What You Will Do:

• Review records related to the general operation and upkeep of a GMP Quality Control laboratory including but not limited to QC test data Quality Event (QE) documents qualification documents and validations.

• Receive log and release incoming supplies and material to the Quality Control laboratory.

• 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 laboratory of pending calibration/preventative maintenance activities.

• Support the maintenance of the CAPA Deviation Environmental Excursion Investigations and Change Control programs.

• Support the maintenance of the Internal and External Audit program with guidance from Management.

• Track analyze and report on Quality Performance Indicators (QPIs).

• Provides QA support and oversight for the resolution of CAPA Deviations Environmental Excursions and Change Control.

• Act as QA reviewer for investigations deviations and CAPA; with limited approval authority as designated by QA Management.

• Participates in Internal Audits to ensure continued adherence to internal procedures and industry best practices.

• Participate in the GMP 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 as they relate to manufacturing of clinical trial material (Phase 1 Phase 3) Positron Emission Tomography (PET) drugs and 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:

• Bachelors degree with a minimum of SEVEN (7) years of experience in quality assurance and/or quality control in a clinical laboratory environment.

• Knowledge of cGMP aseptic processing and microbiology is required.

• Ability to lift 10 30 pounds.

• Excellent hand-eye coordination.

• Strong communications skills both oral and written.

• Excellent analytical organizational and time management skills.

• Ability to rapidly adapt to changing environment and circumstances.

• Ability to work effectively in a team environment.

• Must be able to OBTAIN and MAINTAIN a Federal or DoD PUBLIC TRUST; candidates must obtain approved adjudication of their PUBLIC TRUST prior to onboarding with Guidehouse. Candidates with an ACTIVE PUBLIC TRUST or SUITABILITY are preferred.

What Would Be Nice To Have:

• Preferred fields of study: Microbiology Biological Science or a related discipline.

• Prior experience supporting NIH a plus.

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 Guidehouse

Guidehouse is an Equal Opportunity EmployerProtected Veterans Individuals with Disabilities or any other basis protected by law ordinance or regulation.

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