Job Purpose
Ocugen is seeking a Quality Assurance - Document Control Intern for a 12-week full-time internship for Summer 2025 within the Quality Assurance - Document Control Department located in Malvern, PA. This opportunity will provide hands-on experience in document management principles, handling of GMP and GCP documents in compliance with global regulatory requirements and exposure to regulatory affairs and quality assurance frameworks within a Gene therapy focused Biopharmaceutical industry.
Duties and Responsibilities
The intern(s) will work under the supervision of a Senior Document Control Specialist with Quality Assurance Department at Ocugen in development, maintaining and improving document management processes, while working Veeva Vault Document management systems.
- Support the digitalization and electronic archiving of GxP records within Veeva Vault QualityDocs (VQD), ensuring adherence to document hierarchy.
- Support the document classification, lifecycle, including creation, review, approval, archiving, and accurate recordkeeping of standards, procedures, and work instructions.
- Perform quality checks on regulatory documents, ensuring accurate filing within manual or system repositories while adhering to established procedures.
- Assist in system administration tasks and document lifecycle for accurate record keeping while meeting established regulatory compliance guidelines, company policies and industry standards.
- Participate in conducting compliance checks under the guidance of QA.
- Understand GxP regulations (GMP, GCP and GLP) to ensure adherence to Regulatory and Quality policies and FDA/EMA/Health Canada guidelines.
- Gain a good understanding of regulatory requirements such as CFR 210 & 211 as it applies to document control and compliance.
Qualifications
- The candidate must be 18yrs or older.
- Currently enrolled full-time in an accredited college/university undergraduate program
- Majoring in Business Administration, Management, Information Technology, Pharmaceuticals or Health Sciences
- Proficient in Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- Excellent written and verbal communication skills.
- An open mind and willingness to learn
- Ability to work independently and collaboratively within a high paced team environment.
Working Conditions
The incumbent is expected to work on-site at the Malvern, Pennsylvania office, Monday through Friday during standard business hours for a 10 to 12 week duration.
Physical Conditions
This is a largely sedentary role.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.