QA Document Control Internship

West Pharmaceutical Services•Exton, PA
•Onsite

About The Position

The position provides administrative support to the West Services and Solutions Quality Assurance team. It supports the administration and control of quality records, procedures, laboratory documentation, and related systems to help ensure compliance with company procedures and applicable regulatory requirements. This is an onsite, part-time internship requiring 20 hours per week.

Requirements

  • High school degree required.
  • Currently enrolled in a Bachelor's or Master's degree program.
  • Effective problem-solving and interpersonal skills.
  • Basic proficiency with MS software.
  • Ability to work successfully in a team environment.
  • Good communication and analytical skills, including good grammar.
  • Ability to set priorities and work reliably and in an organized manner.
  • Attention to detail and ability to perform work accurately according to procedures and guidelines.
  • Ability to comply with company safety and quality policies.
  • Ability to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

Nice To Haves

  • A focus in a technical, scientific, or business-related field.
  • 0–3 years of relevant laboratory, manufacturing, quality, or technical experience.
  • Applicable education, laboratory coursework, internships, or hands-on training.
  • Experience in a regulated industry.

Responsibilities

  • Administer quality records, procedures, and controlled documentation in accordance with company procedures and applicable regulatory requirements.
  • Review and help prepare documentation and data packages for approval, including assembling, copying, scanning, filing, and organizing records.
  • File and maintain laboratory operational testing data packages and supporting documentation, ensuring records are complete, accurate, and readily retrievable.
  • Support internal and external audit preparation by retrieving, organizing, and reconciling documentation.
  • Support data integrity practices and help ensure laboratory systems, records, and documentation meet applicable company and regulatory expectations.
  • Create, update, and control forms and plant procedures in compliance with corporate guidelines.
  • Maintain readily retrievable documentation related to validations, qualifications, Batch Records, DMR, and DHF, as applicable.
  • Support administration of laboratory documents and electronic systems to keep documentation 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.
  • Issue controlled documents, including batch records, protocols, logbooks, and controlled copies for internal or external customers and suppliers, in accordance with company policy.
  • Meet individual and department goals.
  • Work independently and collaboratively in a cross-functional team, demonstrating self-motivation, adaptability, and a positive attitude.
  • Comply with applicable regulations, policies, work procedures, instructions, safety rules, and quality and safety policies.
  • Maintain regular, reliable, punctual, and predictable attendance and follow housekeeping practices.
  • Perform other duties as assigned.

Benefits

  • Benefit programs supporting team members' and families' physical, mental, emotional, and financial health.
  • Opportunities for lifelong learning, growth, and development.
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