Quality Control Technician

CalCog, Inc.; Bastrop (TX); On-site; USD 42,000 - 59,000; Full time

Job summary

CalCog, Inc. is seeking a Quality Control Technician to ensure products meet GMP/SOP requirements and regulatory standards. You will perform inspections, document results, and review batch records in collaboration with QA and production teams.

The role requires attention to detail, ability to work independently, and comfortable using Microsoft Office for documentation and data analysis. High school diploma is required; Bachelor's degree is preferred.

Qualifications

• High school diploma or equivalent required.
• Bachelor's degree preferred.
• Experience in a regulated environment preferred.
• 1 year QC experience or equivalent in GxP setting.

Responsibilities

• Ensure SOPs are followed to meet Quality Standards.
• Perform tests and inspections of products and processes.
• Document and report inspection results; report non-conformances to Quality Management.
• Review pre- and post-production batch records for compliance.
• Assist with other Quality-related functions as needed to support site productivity.
• Downtime tasks such as document scanning, warehouse cleaning, and inspections.

Skills

Organizational skills

cGMP knowledge

Interpersonal skills

Attention to detail

Statistical aptitude

Independence

Education

Bachelor's degree (preferred)

High school diploma or equivalent

Tools

Microsoft Office

Job description

Overview

Position Summary: The Quality Control Technician is responsible for knowing regulations and standards associated with pharmaceutical manufacturing including packaging and labeling. They perform product inspections and tests during production to ensure compliance with production specifications, applicable regulations, and SOPs. They ensure that all incoming products and components meet required specifications. They are responsible for completing portions of the production batch record that relate to Quality Control functions.

Organizational Position: This post holder reports directly to the QA Director, or designee, but they will work closely with CalCog’s Client Services, Commercial, Operations, and Regulatory teams.

Responsibilities

• Ensure SOPs are followed to meet Quality Standards, including but not limited to Receiving and Production SOPs.
• Ensure proper use of Personal Protective Equipment.
• Collaborate and communicate with upper management and operations teams on quality-related issues.
• Document and report all inspection results; report all non-conformances related to specifications or standards to Quality Management.
• Conduct tests and/or inspections of products and processes to evaluate quality or performance.
• Work in conjunction with production to ensure the best possible product is produced in accordance with GMPs and internal/external specifications.
• Perform visual inspection of finished product as required by procedure.
• File and maintain archival documentation.
• Verify that incoming products comply with documents specification, including but not limited to drugs, components and labels.
• Review pre- and post-production batch records to ensure compliance with regulatory and internal/external requirements.
• Assist with other Quality-related functions as needed to support site productivity.
• During QC downtime, assist with other facility-related tasks such as document scanning, warehouse cleaning, and inspections.
• Other duties as assigned according to the changing needs of the business.

Qualifications, Experience, and Skills

• High school diploma or equivalent required
• Bachelor's degree (preferred)
• Experience working in a regulated environment (preferred)
• 1 year QC experience or the equivalent combination of education and related work experience in a GxP regulated setting totaling 1 year: Bachelor Degree +0-1 years, Associate Degree +2 years or High School Diploma +3 years relevant work experience

Competencies, Traits and Skills

• Strong organizational skills with multitasking capabilities
• Ability to interpret and apply cGMP and company SOP knowledge
• Strong interpersonal skills and the ability to manage, motivate, and influence quality work behaviors in self and others
• Flexible, enthusiastic and highly motivated to work in a challenging environment
• Proficient knowledge of various computer applications including Microsoft Office
• High attention to detail and statistical aptitude
• Position entails a high level of independence, initiative and requires an aptitude for attention to detail