We are currently searching for a Quality Assurance/Quality Control Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.
Duties & Responsibilities
- 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.
- Bachelor’s degree in a science related discipline.
- Minimum of two (2) years of experience in Quality Assurance or Quality Control.
- Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred but not 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.
Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.Company Description
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.