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Quality System Specialist (QC Compliance)

Quality System Specialist (QC Compliance)

Rishabh RPOHolly Springs, NC, United States
23 hours ago
Job type
  • Full-time
  • Quick Apply
Job description

Job Title :

Quality System Specialist (QC Compliance)

Location :

Holly Springs, NC 27540

Duration : 12 Months (Possible extension for a longer duration)

Job Description :

  • This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive strategic improvements in the services provided to our customers. This role requires having a technical understanding of the QC function. Understanding of the technical scope of the QC function, how the function impacts QC customers, and ensuring compliance with Quality objectives is critical for this role. This role involves interaction within cross-functional teams between multiple departments, including other CSL Seqirus sites, and involves a high level of attention to detail to solve a range of routine and non-routine problems. The individual must be self-motivated and have good organization and time management skills.

Major Accountabilities :

  • Leads deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent recurrence
  • Initiates and performs EDMS workflows. Completes change control, self-inspection, and CAPA Actions
  • Provides support with assigned business process systems to support QC - these systems include SAP, LIMS, EDMS, LMS, etc.
  • Responsible for the Work Order Tracking system for tracking and coordinating the initiation, execution and completion of work orders
  • Track metrics (KPIs) and project statuses. Well-developed presentation skills to deliver presentations to the team / dept and cross-functional groups
  • Able to perform GMP documentation activities and follow specific schedules, with excellent communication skills
  • Works within clearly defined standard operating procedures and / or scientific methods and adheres to quality guidelines
  • Must demonstrate exceptional teamwork behaviors with going above and beyond to help others.

    • Minimum Required Qualifications :

  • High School Diploma or GED
  • One year experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable.
  • Experience working with cGMPs and Industry Standards desirable
  • Experience in reading, understanding, and following Standard Operating Procedures desirable
  • Possess good verbal and written communication skills
  • Possess basic math skills (addition, subtraction, division, multiplication).
  • To be able to multi task in warehouse environment.
  • Possess good organization skills
  • Knowledge of cGMP preferred.

    • Preferred / Nice to Have Qualifications :

  • Knowledge of GMPs
  • Knowledge of safety regulations
  • Knowledge of data integrity.
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    Quality System Specialist • Holly Springs, NC, United States