QA Document Control Internship

Essential Duties and Responsibilities

• Administer quality records, procedures, and controlled documentation in accordance with company procedures and applicable regulatory requirements.
• Review and assist in the preparation of documentation and data packages for approval, including assembling, copying, scanning, filing, and organizing records as needed.
• File and maintain appropriate data packages and support documentation for laboratory operational testing groups, ensuring records are complete, accurate, and readily retrievable.
• Support administrative activities related to internal and external audit preparation, including retrieval, organization, and reconciliation of documentation.
• Support data integrity practices and help ensure laboratory systems, records, and documentation comply with applicable company and regulatory expectations.
• Maintain a system to create, update, and control forms and plant procedures ensuring compliance with corporate guidelines.
• Maintain files for documentation related to validations, qualifications, Batch Records, DMR and DHF as applicable, ensuring these are easily retrievable.
• Support the administration of laboratory documents and electronic systems to help ensure documentation remains current, accurate, and compliant with cGMP standards and internal procedures.
• Review controlled documents for accuracy, completeness, and compliance with established formats, procedures, and documentation practices.
• Issues controlled documents as required, such as batch records, protocols, logbooks as well as controlled document copies to customers (internal or external) and suppliers as per company policy.
• Meet individual and department goals as required.
• Work independently and collaboratively as part of a cross-functional team, demonstrating self-motivation, adaptability, and a positive attitude.
• Conform with and abide by all applicable regulations, policies, work procedures, instructions, and safety rules.
• Exhibit regular, reliable, punctual, and predictable attendance.
• Perform other duties as assigned.

Education

High school degree required. Currently enrolled in a Bachelor's or Master's degree program; focus in a technical, scientific, or business-related field preferred.

Work Experience

0–3 years of relevant laboratory, manufacturing, quality, or technical experience preferred. Entry-level candidates with applicable education, lab coursework, internships, or hands-on training are encouraged to apply.

Preferred Knowledge, Skills and Abilities

• Must have effective problem solving and interpersonal skills.
• Some experience within a regulated industry strongly preferred.
• Experience and basic skill level with MS software required.
• Must be able to work successfully in a team environment.
• Good communication skills and analytical skills, including good grammar.
• Demonstrated ability to set priorities and work in a reliable and organized manner.
• Able to always comply with the company's safety policy.
• Able to always comply with the company's quality policy.
• Accurate work according procedures and guidelines and attention to detail required.
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.