Quality Assurance Assistant

Evonik’s Lafayette facility exclusively supports the pharmaceutical industry and is one of the world’s leading providers of drug delivery technologies. The site is one of the largest contract manufacturing facilities for active pharmaceutical ingredients (APIs) and Evonik’s second-largest location in the United States. With over 700 employees, the facility is expanding with a new $220 million Lipid Innovation Center that will add 300+ new roles and manufacture key pharmaceutical excipients for RNA-based therapies and pandemic preparedness.

About the role

This contract position is based in Lafayette, IN, and is fully onsite. The role involves managing and organizing the QA document library, ensuring technical documents are accurately maintained and accessible.

Responsibilities

• Organize and manage the QA document library, ensuring technical documents are properly accessed when needed.
• Review and update technical documents (Batch Records, SOPs, Training, Lab Protocols, etc.) to maintain accurate documentation in the QA library database.
• Prepare documents for off-site or on-site storage and send them to appropriate locations under the guidance of the Evonik Document Services Team.
• Purge records on shelves according to the site’s records retention schedule, as applicable, under the guidance of the Evonik Document Services Team.
• Print, issue, and coil new laboratory notebooks.
• Process and assist in audits for document retrieval.

Requirements

• 6+ months of experience working within Quality (preferably QA).
• 6+ months of experience working in a GMP environment.
• Proven ability to review and understand technical documents and work within a QMS or other databases.

Qualifications

• Nice to have:
  • Bachelor’s degree in Life Science or a related field.
  • Document Control experience.

Skills

• Quality Assurance
• Documentation
• Inspection
• Batch Record
• SOP
• Data Entry
• GMP
• Document Control
• LIMS
• SAP
• QMS
• Quality Inspect
• Quality Control
• Technical Document
• Quality Check
• Quality Test
• QC Check
• QA Check

Pay

The pay range for this position is $20.00 - $22.00 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

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