QC Analyst
Spectraforce
Indianapolis, Indiana
24 days ago
Job Description
Job Title: QC Analyst
Location: Indianapolis, IN 46268
Duration: 12 Months
This shift will be: Friday - Tuesday, 4:00pm - 12:30AM
Description:
The QC Analyst is responsible for performing tasks associated with release testing and reviewing laboratory data. Communicating with and supporting internal & external partners of the Quality Control organization.
Key Responsibilities:
• Provide support to peers within the Quality Assurance, Quality Control and AS&T teams.
• On-time and GMP-compliant release of patient batches
• Support Quality Control and AS&T as a valued business partner, with a culture of safety, quality,
delivery to patients, cost, compliance, and data integrity.
• Author, review and support procedures, investigations, corrective and preventive actions, change
controls, complaints, and training as it relates to quality control testing.
• Ensure that QC testing is properly conducted and documented for all performed activities, with
emphasis on Data Integrity. Evaluate and approve QC records as required.
• Provide oversight and monitoring of quality control KPIs and programs.
• Perform QC related validations, transfers, improvements, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
• Prepare and participate in health authorities’ inspections and internal audits of QC. Ensure quality control area is inspection ready.
Essential Requirements:
• BSc in Chemistry or relevant scientific
• 3+ years of experience in a GMP quality control environment
• Strong HPLC experience a must
• General HSE Knowledge
• Knowledge of GMP Manufacturing Process Execution
• Quality Control (QC) Testing
• Quality Control Sampling
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.
Location: Indianapolis, IN 46268
Duration: 12 Months
This shift will be: Friday - Tuesday, 4:00pm - 12:30AM
Description:
The QC Analyst is responsible for performing tasks associated with release testing and reviewing laboratory data. Communicating with and supporting internal & external partners of the Quality Control organization.
Key Responsibilities:
• Provide support to peers within the Quality Assurance, Quality Control and AS&T teams.
• On-time and GMP-compliant release of patient batches
• Support Quality Control and AS&T as a valued business partner, with a culture of safety, quality,
delivery to patients, cost, compliance, and data integrity.
• Author, review and support procedures, investigations, corrective and preventive actions, change
controls, complaints, and training as it relates to quality control testing.
• Ensure that QC testing is properly conducted and documented for all performed activities, with
emphasis on Data Integrity. Evaluate and approve QC records as required.
• Provide oversight and monitoring of quality control KPIs and programs.
• Perform QC related validations, transfers, improvements, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
• Prepare and participate in health authorities’ inspections and internal audits of QC. Ensure quality control area is inspection ready.
Essential Requirements:
• BSc in Chemistry or relevant scientific
• 3+ years of experience in a GMP quality control environment
• Strong HPLC experience a must
• General HSE Knowledge
• Knowledge of GMP Manufacturing Process Execution
• Quality Control (QC) Testing
• Quality Control Sampling
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.