Quality Assurance Associate

Your Role:

To ensure that all aspects of site production operate within all established quality systems. You will support the cGMP and/or ISO 9001 quality systems such as training, batch record reviews and documentation control. Responsibilities and tasks include:

• Safely perform operations to meet quality expectations.
• Improve quality systems in both GMP and ISO production and packaging environments.
• Drive quality improvement in multiple departments
• Be the “voice of quality” on the production and packaging floors performing routine walk through. o Review quality documents in production and packing areas.
• Assist Quality Team issuing and reviewing batch records for GMP manufacturing.
• Review ISO and GMP in-process batch records and form for good documentation.
• Communicate the status of operations and bring critical deviations to the attention of the appropriate parties.
• Communicate with coworkers and interact with other departments regularly.
• Complete and have accurate work consistently with quality guidelines.
• Take note of details and ensure others do as well.
• Assist in maintaining department KPIs through on time CAPAs, Deviations, and Complaints.
• Assist in compliance with Life Science and site quality policies and procedures.
• Ability to serve on committees to improve department, site, or company performance. Committees may focus on safety, quality, inventory, output, costs, etc.
• In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles.

Who You Are

Minimum Qualifications:

• High School Diploma or GED
• 2+ years of experience in a quality role at a GMP manufacturing facility

OR

• Associate’s degree in any discipline.
• 1+ years of experience in a quality role at a GMP manufacturing facility.

Preferred Qualifications:

• Bachelor's degree in chemistry, Biology, or other science discipline.
• Previous QA experience in a GMP manufacturing or testing facility.
• 3-5 years’ work experience in a GMP Manufacturing Facility.
• Experience with quality management systems such as Trackwise, electronic document management systems, etc.
• Ability to multitask and prioritize.
• Understanding of ISO and cGMP quality standards.
• Computer literacy, including Microsoft Word and Excel.