QA Associate I - Process

Core Hours

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

Purpose and Scope

The Quality Assurance Associate I is responsible for the inspection, testing, record keeping and overall quality assurance support to manufacturing.

Essential Duties & Responsibilities

• Inspect material, components, and finished product against specified requirements.
• Follow procedures to determine status or disposition, and properly document results on records and in lab notebooks.
• Support manufacturing and QC unit with inspections and material sampling.
• Complete training according to requirements and maintain training records in the electronic document system.
• Perform finished product inspections in accordance with specification; ensuring proper sampling has taken place prior to final release.
• Provide process oversight support to manufacturing.
• Ensure proper status and storage of materials and product.
• Complete review and release of materials as required.
• Provide quality oversight throughout multiple departments and facilities.
• Initiate deviations and complete immediate actions.
• Participate in monthly quality and safety walkthroughs.
• 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 I 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.
  

Education & Experience

• High school diploma, GED, or equivalent required.
• Associate’s degree preferred.
• Experience in a high volume manufacturing environment preferred.
• Experience in a Quality Assurance capacity in the pharmaceutical or medical device industry preferred.
  
  

Additional Requirements

• Ability to bend, squat, and lift minimum of 30 pounds required.
• Ability to pass physical and eye exam required. Ability see color.
  
  

Working Conditions

• Working conditions are in an office, warehouse and manufacturing environment.
• Occasional overtime may be required.
• Work may consist of travel between multiple facilities.
  
  

Compensation And Benefits

• Pay: $19.62 per hour
• Benefits information: https://www.tolmar.com/careers/employee-benefits
  
  

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.