QA Specialist

Guidehouse

1d•$85,000 - $141,000

About The Position

We are currently searching for a Quality Assurance (QA) Specialist to provide support to the National Institutes of Health (NIH). 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 Good Manufacturing Practice (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, onboarding 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.

Requirements

Bachelor’s degree.
Minimum of three (3) years of on-the-floor Quality Assurance (QA) experience.
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.

Nice To Haves

Preferred fields of study: Microbiology, Biological Science, or a related discipline.
Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred but not required.

Responsibilities

Review records related to the general operation and upkeep of a Good Manufacturing Practice (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, onboarding 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.

Benefits

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 bonus