Quality System Specialist (QC Compliance)

Rishabh RPO

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

Job Title: Quality System Specialist (QC Compliance) Location: Holly Springs NC 27540 Duration: 12 Months (Possible extension for a longer duration) Job Description: ...