QA Associate

Job Title:

QA Associate

Job Description
The QA Associate is responsible for the review and analysis of data supporting the quality of products and packaging, ensuring compliance with applicable procedures, current Good Manufacturing Practices (cGMPs), standards, and regulations.

• Provide support to Quality systems.
• Organize, critically review, and present information in accordance with written procedures.
• Provide support for the production area.
• Apply and obtain statistical analysis.
• Write, review, and revise GMP standard operating procedures.
• Track, maintain, and critically review and correct manufacturing records (tickets). Print additional documentation to include with manufacturing records for disposition.
• Maintain communication with QC lab regarding test results pertinent to batch release.
• Maintain communication with Supply Chain Representatives to ensure batch manufacturing records are released in a timely manner.
• Approve raw materials for use in production areas, which includes evaluating vendor certificates of analysis (COAs), printing permits, approving materials as they arrive on site, blocking and unblocking material, tracking vendor information on a shared site, and maintaining communication with material control officers (MCOs).
• Print and prepare batch manufacturing records as requested by Supply Chain, including manually printing product shipping labels, verifying count and variable data information, tracking and creating additional labels as needed, and maintaining communication with area inventory control officers (ICOs).
• Create or prepare Certificates of Analysis as requested by Customer Service Representatives, including the creation of AQIS documents and permits, updating Health and Non-Radiation Certifications, creating Certificates of Manufacturing and Certificates of Conformity, tracking COA requests, and mailing documents.
• Perform inbound Quality Analysis and receipt for printed packaging materials. Approve printed packaging materials for use in production areas.
• Monitor temperature records of bulk material received for Companion Animal Products.
• Approve bulk material received for Companion Animal Products.
• Own, track, and route documents in Veeva Vault for edit, review, and approval as needed for Quality Assurance Representatives and Technical Service/Manufacturing Science Representatives.

• Quality Assurance
• Batch Record
• GMP
• Batch Record Review
• Pharmaceutical
• Life Science
• Quality Inspection
• Titration
• Quality Documentation
• pH Testing
• Analytical Skills
• Biology
• Chemistry
• COA
• Laboratory Experience
• QA Testing
• QA Checking
• QA Documentation
• SOP Review

• B.S/A.S Degree in related field OR 12+ months of QA/GMP experience without a degree
• Strong communication, documentation, and math skills
• Proficiency with computers
• Attention to detail with the ability to work well in a highly regulated environment
• Experience in Batch Record Review is a plus

The work environment is a manufacturing setting producing solid dosage medicine/nutrients/vitamins for animal feed products, as well as pre-mix pharmaceutical products. It varies between environments that are very clean to those that are much dirtier. Employees wear a uniform and can expect to go home dirty, unlike the cleaner environments. The facility includes a full-service cafeteria with hot and cold food, vending machines, and a lunchroom.

Night shift has a functional lunchroom, while the day shift enjoys full service. Work hours are from 7:30 am to 4:00 pm, Monday to Friday.

This is a Contract to Hire position based out of Clinton, IN.

The pay range for this position is $24.00 - $24.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick…