Quality Assurance Support Intern

Provide supervised, office-based support to the Quality Assurance team through archive organization, document readiness activities, checklist-based pre-review support, binder completeness verification, reporting support, and administrative QA tasks. The role is structured to provide practical exposure to pharmaceutical quality systems while maintaining no independent GMP decision-making authority. The QA Support Intern supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Job Responsibilities:

Archive space-saving and document organization

• Move eligible archived documents from large binders into smaller binders using a preapproved transfer method and indexing convention.
•  Update binder spine labels, contents sheets, and archive location logs.
• Create before/after cabinet capacity records to support a repeatable space-saving practice.
• Maintain a transfer log so QA can trace where each document set was moved.

Archive indexing and retrieval readiness

• Build or update archive inventories, metadata sheets, and retrieval maps.
• Standardize naming conventions and flag duplicate, obsolete, or difficult-to-retrieve files for supervisor review.
• Prepare an archive quick-reference guide for future retrieval and filing consistency.

Work order pre-review support

• Review completed work orders against a QA-prepared checklist for presence, legibility, signatures/initials, dates, attachments, and obvious inconsistencies.
• Record observations on a separate review sheet without marking the original work order.
• Sort findings by type so the qualified reviewer can focus quickly on likely issues.
• Prepare work orders in organized review batches for Vasantha or other assigned QA staff.

IOPQ equipment binder routine review support

• Review IOPQ binders using a standard completeness checklist.
• Check whether expected sections, protocols, reports, approvals, attachments, traceability items, and referenced forms are present. Flag missing or inconsistent content on a separate checklist.
• Perform routine verification against open deviations, linked actions, and assigned CAPA-related follow-up items where this has been predefined by QA.
• Prepare a summary sheet showing what is present, what is missing, and what requires qualified QA assessment.

QC IOPQ equipment binder routine review support

•  Apply the same checklist-based review model to QC binders.
• Check section completeness, document order, signatures, dates, attachments, referenced worksheets/results, and filing consistency.
• Flag missing or mismatched items without writing on original GMP records.
• Cross-check predefined items against open deviations and applicable follow-up actions when assigned by QA.
• Prepare QC binder summary sheets for qualified reviewer follow-up.

Metrics and reporting support

• Maintain weekly progress trackers for binders reviewed, archive volumes reduced, issues logged for QA review, and training aids drafted.
• Prepare simple summary dashboards or status sheets from approved data sets.
• Support end-of-internship reporting with before/after examples and quantified outputs.

General Office Support - QA and general Operations

• Provide support as needed (scan/organization) to office work in QA and other teams (ie COO, Manufacturing, etc).

Required Knowledge Skills and Abilities:

• Strong attention to detail and organizational skills.
• Ability to follow SOPs, checklists, and documented processes.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Written and verbal communication skills
• Ability to handle confidential information
• Basic understanding of document control principles preferred
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
•  Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Education and Experience Requirement :

Current high school, undergraduate or graduate students with interest in Life Sciences, Pharmacy, Biotechnology, Quality, Engineering, or related discipline.

Compensation:

$16-$20 per hour

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

Salary : $16 - $20