Quality Assurance Specialist

4 weeks ago

Baltimore, Maryland, United States C-Care Full time
Job Title: Quality Control Technician

At C-Care, we are seeking a highly skilled Quality Control Technician to join our team. As a Quality Control Technician, you will play a critical role in ensuring the manufacturing and filling production lines generate a consistently suitable output of products that meet quality and efficiency standards.

Key Responsibilities:
  • Assist in Quality department efforts in inspection and testing of received, and in-process materials, components, and products to ensure adherence to established quality standards.
  • Perform quality checks including but not limited to: start-up procedures and 30-minute checks, pallet check assessments, labeling assessment, product organoleptic evaluation, and batch related information assurance.
  • Ensure both self, and other QC technicians, as well as specialized Production employees tasked with quality tasks, all are maintaining all quality checks in accordance with the site Quality Management Program.
  • Assist in the development of an enhanced quality control process within C-Care, to include warehouse, receiving, mixing/compounding, and filling areas.
  • Assist Quality Control Manager, as well as Director of Quality on driving deviation reporting and non-conformity observations from all areas of the facility to Quality Assurance management, Director of Quality and production staff and management as needed.
  • Assist in the development of a robust, communicative, and controlled quality process with the Director of Quality and Technical Services Manager.
  • Voice and escalate concerns including quality deviations, employee safety and/or management issues, and all hazard control areas within the facility.
  • Demonstrate proactive thinking and critical, rapid correction as needed.
  • Assist in development and evaluation of new procedures and protocols with the Director of Quality.
  • Verification of checklist paperwork and/or electronic records daily.
  • Deliver quality results and recordkeeping.
  • Attend EHS meetings and discuss potential risks and issues.
  • Maintain critical awareness of all areas of the facility with respect to quality and hazard control.
Qualifications:
  • B.S. or B.A. in a related field.
  • 2+ years of prior experience in a quality control role with direct experience in observing product quality within a manufacturing process and environment.
  • Prior experience with reviewing batch records, start-up records, 30-min checklists and all other quality documentation for verification purposes is preferred.
  • Prior training as an ISO 22716 Lead Auditor and Internal Auditing, HACCP and FDA GMP/OTC guidelines within 21 CFR is a plus.
  • Ability to work independently without supervision in a deadline-driven environment.
  • Ability to communicate effectively with all levels of management, both written & orally.
  • Must be detail-oriented with excellent organizational skills.
  • Prior experience with MS Office applications like Word and Excel.
  • Availability and willingness to work flexible hours including some nights and weekends to meet customer needs.
  • Sampling of materials may require lifting of drum lids and/or shifting of 55lb. Bags; Lifting of 5g reagent chemical drums; walking throughout facility (140,000 sq. ft.) and climbing stairs to processing area.

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