QA Associate III - Process (3rd Shift)

Tolmar•Fort Collins, CO

1d•$25 - $27•Onsite

About The Position

The Quality Assurance Associate ensures that all products manufactured at Tolmar are manufactured in accordance with current Good Manufacturing Practices (GMP) and meet internal specifications. The role continuously monitors systems and procedures for compliance with applicable regulatory and industry standards, quality improvement, and efficiency. The associate provides quality oversight and process support across manufacturing departments and facilities, inspects and releases materials and finished products, maintains accurate documentation, and supports investigations and corrective and preventive actions. The role also contributes to training, prioritizes group tasks, and helps ensure facility staffing coverage.

Requirements

Working knowledge of drug or device cGMP.
Knowledge of computer operations, including proficiency with MS Word, Excel, and Access.
Ability to learn Tolmar electronic systems.
Strong organizational skills and attention to detail.
Strong written and oral communication skills.
Ability to work independently and prioritize tasks with limited supervision.
Ability to work effectively with employees at all levels and across departments.
Ability to read, understand, and follow procedures.
Competency in technical writing.
Ability to apply critical thinking to non-conformances and potential areas of concern.
Four or more years of experience in the pharmaceutical or medical device industry in a Quality Assurance capacity.
High school diploma or GED.
Ability to bend, squat, and lift a minimum of 30 pounds.
Ability to pass a physical and eye exam.
Ability to see color.

Nice To Haves

Associate’s degree.
Experience in a high-volume manufacturing environment.
Experience in a Quality Assurance capacity in the pharmaceutical or medical device industry.

Responsibilities

Inspect materials, components, and finished products against specified requirements.
Determine and document material or product status and disposition in records and lab notebooks.
Inspect retained drug product for Annual Product Reviews.
Support manufacturing and QC units with inspections and material sampling.
Train associates on job functions and maintain required training records in the electronic document system.
Ensure proper status and storage of materials and products, and provide materials to other departments as requested.
Update, review, and approve SOPs and work instructions through the electronic document management system.
Review and release materials, including generating Certificates of Analysis (COAs) through LIMS.
Provide quality oversight across multiple departments and facilities and process oversight support to manufacturing.
Initiate deviations, complete immediate actions, and request assessments of non-conformances from appropriate groups.
Perform finished-product inspections and verify appropriate sampling before final release.
Use electronic document and documentation systems in performing duties.
Suggest improvements to inspection and documentation processes and work with manufacturing to support their implementation.
Participate in monthly quality and safety walkthroughs.
Review temperature data loggers.
Lead investigations involving QA manufacturing support processes and complete corrective and preventive actions identified through investigations.
Contribute to Competency Based Training as a subject matter expert in a Developer, Trainer, or Assessor capacity.
Make sound quality decisions with little or no supervision and prioritize daily group tasks.
Create and maintain staffing schedules to ensure appropriate coverage at each facility.
Perform other duties as assigned.