Quality Assurance Assistant
About the role
The Quality Assurance Assistant supports a large pharmaceutical manufacturing facility by organizing, maintaining, and controlling quality documentation within the QA document library. This role helps ensure accurate, compliant, and easily accessible technical records that support the production of active pharmaceutical ingredients and key pharmaceutical excipients for innovative therapies.
Responsibilities
- Maintain and organize the QA document library so that technical documents are properly filed and easily accessible when needed.
- Review technical documents such as batch records, standard operating procedures (SOPs), training materials, and laboratory protocols to ensure they are accurate and up to date in the QA library database.
- Update document information and metadata within quality systems and databases to maintain accurate and consistent documentation.
- Prepare documents for off-site and on-site storage and send them to appropriate locations under the guidance of the Document Services Team for the QA library.
- Purge records from shelves according to the site records retention schedule under the guidance of the Document Services Team.
- Print, issue, and coil new laboratory notebooks for use by laboratory and technical staff.
- Support audits by retrieving and providing requested documents in a timely and organized manner.
- Perform data entry related to quality documentation in systems such as QMS, LIMS, and SAP as required.
- Assist with quality checks on documentation to support compliance with GMP and site quality standards.
Essential Skills
- At least 6 months of experience working within a Quality function, preferably in Quality Assurance.
- At least 6 months of experience working in a Good Manufacturing Practice (GMP) environment.
- Proven ability to review and understand technical documents such as batch records, SOPs, training materials, and lab protocols.
- Experience working within a Quality Management System (QMS) or other databases for document control and record management.
- Knowledge of quality assurance principles and practices, including quality checks and inspections.
- Ability to perform accurate data entry and maintain detailed documentation.
- Familiarity with document control processes and quality documentation requirements.
- Experience with or exposure to systems such as LIMS and SAP in a quality or documentation context.
- Understanding of quality control and quality inspection activities related to documentation, including QA checks and QC checks.
- Ability to work with technical documents and ensure they meet quality and compliance standards.
Qualifications
- Bachelor's degree in a Life Science or related field is preferred.
- Prior document control experience in a regulated or GMP environment is a strong plus.
- Experience working with QMS, LIMS, SAP, or similar quality and documentation systems.
- Familiarity with quality documentation, inspection, and testing processes in a pharmaceutical or manufacturing setting.
- Strong organizational skills and attention to detail when handling large volumes of technical documents.
- Ability to support audits by efficiently retrieving and organizing documentation.
- Comfort working with batch records, SOPs, and other technical documents in a structured, compliance-driven environment.
Work Environment
This role is based onsite at a large pharmaceutical manufacturing facility that supports the production of active pharmaceutical ingredients and key excipients for advanced therapies. The Quality Assurance Assistant will spend nearly all working time in the QA office area, focusing on documentation and quality systems. The standard schedule is Monday through Friday, typically 9:00 a.m. to 5:00 p.m., with flexibility for start times between 6:00 a.m. and 6:00 p.m. The environment is professional and compliance-focused, with close collaboration with QA and document services teams. While on assignment, paid time off is available (1–2 weeks), and pay is provided for six major holidays: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving, and Christmas.
This is a Contract position based out of Lafayette, IN.
Pay
- $20.00 - $22.00/hr
Benefits
- 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 Leave)