Overview
Director of Quality Assurance Jobs in Phoenix, AZ at Greenberry Industrial
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 Quality Control (QC) SPecialist inspection and disposition of received, kitted, and picked/packed pharmaceuticals, vaccines, medical devices, and other medical supply items in support of Federal Agency storage and distribution. Provides QC Support for warehouse operations and customer projects, ensuring compliance with applicable laws/regulations (e.g., DSCSA, cGMPs), local procedures, customer requirements, and best practices (Good Storage Practices and Good Distribution Practices). The QC Senior Associate provides support to the QC Lead and guidance to junior QC Associates.
Responsibilities Include:
Perform QC inspection of received, kitted, and picked/packed medical supply items to verify they are fit for distribution, including damage, compliance with labeled temperature storage requirements (e.g., cold chain), material accuracy, quantity, DSCSA traceability, and other quality criteria per applicable regulations, local procedures, and customer-specific requirements.
Responsible for release disposition of received or picked/packed items meeting acceptance criteria and quarantining items that do not meet acceptance criteria physically and electronically using a computerized Warehouse Management System.
Initiate Item Discrepancy Reports and/or Deviation Reports for items that do not meet acceptance criteria or other Quality issues that occur within the Warehouse. Perform investigations, document resolution, and provide a suitable rationale for the disposition of product to be released or rejected. It may require contacting suppliers or manufacturers to determine the product’s suitability. Escalate issues to Quality Assurance, requiring in-depth investigation and dispositioning.
Follow up with suppliers for required traceability information for compliance to DSCSA.
Work collaboratively and maintain a professional, courteous, approachable, and positive working relationship with Federal and Contract Quality Assurance, Logistics, Project, and other staff and management to ensure the timely completion of assigned tasks and resolution of issues.
Maintain accurate and complete records of activities performed using the electronic inventory management system or paper-based documentation.
Provide Quality support and/or guidance for general warehouse operations.
Perform internal Quality audits as requested by the warehouse and applicable operations to verify compliance with applicable regulations, local procedures, customer requirements, and best practices, including the accuracy of physical and electronic inventories. Track responses and CAPAs to ensure observations are addressed. Peer review audit reports for accuracy, validity, and spelling/grammar.
Support developing or revising procedures or checklists to support and continually improve processes, ensuring quality and compliance to applicable procedural or regulatory requirements and professional workmanship.
Track metrics relevant to duties such as results of receiving/kitting/picking/packing inspections, Item Discrepancy Reports, DSCSA Exceptions and internal audits.
Support customers in meeting critical timelines in which pre-approved overtime work may be required.
Provide high-quality and professional workmanship when performing tasks.
Receive training and maintain certification to operate a forklift or similar material handling equipment as required.
Complete assigned training in a timely manner.
Maintain a clean and safe work environment.
Follow all safety protocols, including but not limited to warehouse safety.
Travel between Perry Point and North East, MD facilities as directed.
Provide support and guidance to junior QC team members.
Location: Onsite, Perry Point, MD and NorthEast, MD
Required Knowledge, Skills, or Experience:
A commitment to adhere to the Quality Management System, ensuring compliance with applicable regulatory and customer requirements.
Excellent attention to detail assures the accuracy of QC inspections, internal audits, documentation reviews, and information recording.
Have a mindset for continual improvement to ensure the highest quality and professional standards are obtained, compliance with applicable procedures or regulatory requirements, a safe work environment, and maximum efficiency.
Possess strong written, verbal, and interpersonal skills. Have the ability to communicate effectively and professionally and interact with staff with assorted disabilities.
Ability to read and interpret documents and follow established procedures.
Capable of troubleshooting and resolving issues, collaborating with colleagues to determine appropriate corrective and preventive actions.
Ability to work in a team setting or independently when needed.
Have good basic math skills.
Must be comfortable using computers, web-based applications and Microsoft Word/Excel.
Understand essential Quality duties such as sampling, inspecting, verifying, releasing, quarantining, and rejecting.
Familiarity with the Drug Supply Chain Security Act (DSCSA), current Good Manufacturing Practices (cGMPs), Good Storage Practices (GSPs), Good Distribution Practices (GDPs), Good Documentation Practices (GDocP), Acceptable Quality Level (AQL), ISO 9001, or other similar Quality/industry standards a plus.
Experience in cold chain handling such as the receipt, storage, monitoring, and/or shipping of refrigerated or frozen products a plus.
Prior experience operating a forklift or similar material handling equipment is a plus.
Required Education and Work Experience:
High School Diploma/GED equivalent.
Minimum of at least 5 years of work experience working in a warehouse, distribution center, or other logistical operations facility or as a Quality Associate in the pharmaceutical, food, manufacturing, or logistics industry.
Must be able to obtain and maintain a Federal Employment Public Trust clearance.
Physical Demands And Working Conditions:
Regular attendance and maintaining a good attendance record are essential functions of the job.
The ability to lift, carry, push, and pull items weighing up to 50 pounds or heavier items using the proper material handling equipment. Required as part of QC inspection of received and picked/packed items in which heavy items may have to be moved or picked up. Quality support of customer kitting projects (tri-wall inspections) requires picking up boxes from a large, palletized container and restacking them to verify pertinent information on each box.
Shabas Solutions offers an extensive benefits package and a competitive salary. Shabas Solutions is proud to be an equal-opportunity workplace. Shabas Solutions is committed to providing jobs for everyone without discrimination based on race, color, religion, sexual orientation, gender identity, national origin, or veteran status. Employment eligibility will be verified using E-Verify.
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Title: Director of Quality Assurance
Company: Greenberry Industrial
Location: Phoenix, AZ
