QA Associate II - Process (3rd Shift)

Core Hours

Sunday - Wednesday, 5:00 pm - 5:30 am, every other Wednesday off

Purpose and Scope

The Quality Assurance Associate II ensures that all product manufactured at Tolmar is manufactured in accordance with current Good Manufacturing Practices (GMP) and meet all internal specifications. They will also provide oversight and guidance to manufacturing personnel in the performance of their duties.

Essential Duties & Responsibilities

• Inspect materials, components, and finished product against specified requirements.
• Follow procedures to determine status or disposition, and properly document results on records and in lab notebooks.
• Perform inspection of retained drug product for Annual Product Reviews.
• Support manufacturing and QC unit with inspections and material sampling.
• Training of associates on various job functions.
• Complete training according to requirements and maintain training records in the electronic document system.
• Ensure proper status and storage of materials and product.
• Provide materials to outside departments as requested.
• Update SOPs and work instructions using the electronic document management system.
• Complete review and release of materials as required.
• Provide quality oversight throughout multiple departments and facilities.
• Initiate deviations, complete immediate actions and request assessments for non-conformances from appropriate groups (i.e. Packaging Engineering).
• Participate in monthly quality and safety walkthroughs.
• Perform finished product inspections in accordance with specification; ensuring proper sampling has taken place prior to final release.
• Provide process oversight support to manufacturing.
• Understand and use the electronic document/documentation system in the performance of duties.
• Suggest improvements to streamline inspection and documentation processes and work with manufacturing department to assure success.
• Demonstrate high level of proficiency in department job functions.
• Reach sound, effective conclusions and make quality decisions with little or no supervision.
• Assist Quality Assurance management with investigations.
• Complete corrective and preventative actions as determined through investigations.
• Contribute to Competency Based Training (CBT) as a subject matter expert, acting in a Developer, Trainer or Assessor capacity.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities 

• Working knowledge in drug or device cGMP.
• Knowledge of computer operations, including proficiency with MS Word, Excel and Access.
• Ability to learn Tolmar’s electronic systems.
• Skill in organization and attention to detail.
• Skill in effective written and oral communication.
• Work independently and properly prioritize tasks with limited supervision.
• Ability to work well with employees at all levels and departments.
• Ability to read, understand and follow procedures.
• Demonstrate competency in technical writing.
• Ability to use critical thinking to address potential areas of concern.

Core Values

The QA Associate II is expected to operate within the framework of Tolmar’s Core Values:

• Center on People:  We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​
• Are Proactive & Agile:  We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​
• Act Ethically:  We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• ​Constantly Improve:  We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​
• Are Accountable:  We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​