QA Document Control Internship

This is an onsite position requiring the team member to be onsite for all scheduled workdays. No relocation assistance is provided for this opportunity.

This is a part-time position (20 hours per week).

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The position is responsible for administrative support activities within the West Services and Solutions Quality Assurance team. This role 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.

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. #LI-AP1 #LI-ONSITE

Additional Responsibilities

• Follow all safety rules and safety procedures.
• Must observe all good housekeeping practices.
• Regular attendance is a requirement of this position.

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.

Travel Requirements

None: No travel required

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.