Job Description
Shabas Solutions, LLC is a woman-owned small business consulting firm providing expertise in scientific, technical, regulatory affairs, quality management, logistics, and project management to public and private sector organizations.
Shabas is looking for a Quality Control Specialist. The QC Specialist inspects and dispositions received, kitted, and packed pharmaceuticals, vaccines, medical devices, and other medical supplies in support of Federal Agency storage and distribution. Provides QC support for warehouse operations and customer projects, ensuring compliance with laws/regulations (e.g., DSCSA, cGMPs), procedures, and best practices (GSP, GDP). The Senior Associate supports the QC Lead and guides junior QC Associates.
Responsibilities Include:
- Perform QC inspections to verify items are fit for distribution, checking for damage, temperature compliance, accuracy, quantity, DSCSA traceability, and other quality criteria.
- Responsible for release of acceptable items and quarantining non-conforming items using a Warehouse Management System.
- Initiate discrepancy and deviation reports for issues, perform investigations, document resolutions, and communicate dispositions, including contacting suppliers if needed.
- Follow up on traceability information with suppliers for DSCSA compliance.
- Collaborate professionally with QA, logistics, project staff, and management to ensure timely task completion.
- Maintain accurate records of activities using electronic or paper documentation.
- Provide QC support and guidance for warehouse operations.
- Conduct internal quality audits to verify compliance and track responses and CAPAs.
- Support procedure development and process improvements.
- Track relevant metrics such as inspection results, discrepancy reports, and audits.
- Assist customers in meeting critical timelines, including overtime work if necessary.
- Perform tasks with professionalism and quality workmanship.
- Receive and maintain forklift operation certification if required.
- Complete training promptly and maintain a safe, clean work environment, following safety protocols.
- Travel between Perry Point and NorthEast, MD facilities as directed.
- Support and guide junior QC team members.
Location: Onsite, Perry Point, MD and NorthEast, MD
Required Knowledge, Skills, or Experience:
- Commitment to Quality Management System and compliance with regulations.
- Strong attention to detail and accuracy in inspections and documentation.
- Continuous improvement mindset for quality and efficiency.
- Effective communication skills, both written and verbal, with diverse staff.
- Ability to interpret procedures and documents.
- Troubleshooting and problem-solving skills.
- Ability to work independently or in a team.
- Basic math skills and proficiency with computers, including MS Word and Excel.
- Understanding of quality duties like sampling, inspecting, verifying, releasing, quarantining, and rejecting.
- Familiarity with DSCSA, cGMPs, GSPs, GDPs, GDocP, AQL, ISO 9001, or similar standards is a plus.
- Experience with cold chain handling is a plus.
- Forklift operation experience is a plus.
Required Education and Work Experience:
- High School Diploma or GED.
- At least 5 years of experience in warehouse, distribution, logistics, or as a Quality Associate in related industries.
- Ability to obtain and maintain a Federal Public Trust clearance.
Physical Demands and Working Conditions:
- Regular attendance is required.
- Ability to lift and move items up to 50 pounds, including heavy or palletized goods.
Shabas Solutions offers extensive benefits and a competitive salary. We are an equal opportunity employer and committed to diversity. Employment is verified via E-Verify.