QA Associate - Batch Record Review

Job Title: QA Associate - Batch Record Review

Job Description

Perform detailed batch record review for manufacturing, packaging, and labeling operations to ensure accuracy, completeness, and compliance with cGMP requirements, including in a sterile manufacturing facility. Verify that all critical process steps, test results, deviations, and yields are properly documented. Identify documentation errors, inconsistencies, or missing information and coordinate corrections with Manufacturing, Quality Control, and other departments.

Responsibilities

• Review equipment cleaning logs, line clearance forms, and related production documents.
• Support lot disposition activities by preparing QA documentation packets for final review.
• Assist in investigating deviations, nonconformances, and CAPAs as needed.
• Participate in internal audits and support external regulatory inspections.
• Maintain QA documentation according to standard operating procedures.
• Recommend process and documentation improvements to increase compliance and efficiency.

Essential Skills

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related discipline.
• 1–3+ years of experience in pharmaceutical, biotech, or regulated manufacturing environments.
• Strong understanding of cGMP, FDA regulations, and batch documentation requirements.
• Excellent attention to detail and strong organizational skills.
• Ability to communicate effectively across multiple departments.

Additional Skills & Qualifications

• Experience with SAP is a plus.
• Experience with some form of EMR is required.

Work Environment

The QA department is divided into two teams: QA Operations and QA Systems, with approximately 8 people across both teams. The QA Operations team handles batch record review, AQL, inspections, temperature checks, and label and vial review, while the QA Systems team manages document control, QMCS, calibration, change controls, deviations, investigations, and CAPAs. Employees may have responsibilities in both departments. The work schedule is Monday through Friday, from 8 am to 4:30 pm.

This is a Contract to Hire position based out of Port Washington, NY.

The pay range for this position is $28.85 - $31.25/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Port Washington,NY.

This position is anticipated to close on Feb 28, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.