Quality Assurance Specialist

Job Family:

Research Analyst (Digital)

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:

We are currently searching for a Quality Assurance Specialist to provide support to the National Institutes of Health (NIH).

• 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:

• Bachelor’s degree in a science related discipline.
• Minimum of 3 years of on-the-floor QA experience.
• 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.
• Work will be performed in a cGMP laboratory setting on a varied schedule per week and may include weekends, holidays, and on-call.

What Would Be Nice To Have:

• Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred but not required.

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

• Care.com 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 b