QA Specialist

QA Batch Record Reviewer / Quality Assurance Specialist

The QA Batch Record Reviewer will support Quality Assurance operations within a regulated manufacturing environment by ensuring batch documentation, investigations, and quality systems activities comply with GMP, GDP, FDA, and ISO 13485 requirements. This individual will play a key role in batch record review, material release activities, deviation investigations, CAPAs, change controls, and SOP development to support product quality and regulatory compliance.

Key Responsibilities

• Perform detailed review of batch production records and manufacturing documentation to ensure completeness, accuracy, and compliance prior to product release.
• Review incoming raw material and component documentation for approval and release into inventory.
• Support investigations for major, minor, and critical deviations, identifying root causes and assisting with implementation of corrective and preventive actions (CAPAs).
• Participate in nonconformance investigations and quality event management activities.
• Author, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and quality documentation.
• Create, review, and process change controls to support continuous improvement initiatives and operational changes.
• Ensure all QA documentation practices adhere to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), FDA regulations, and ISO 13485 standards.
• Collaborate cross-functionally with Manufacturing, Quality Control, Regulatory Affairs, and Supply Chain teams to resolve quality-related issues.
• Assist with internal audits, inspections, and readiness activities for regulatory and customer audits.
• Maintain accurate records within quality management systems and support data trending and quality metrics reporting.

Required Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline preferred.
• 1-2 years of Quality Assurance experience within a GMP-regulated environment.
• Experience reviewing batch records, manufacturing documentation, or quality records.
• Working knowledge of GMP, GDP, FDA regulations, and quality systems.
• Familiarity with deviation investigations, CAPAs, change controls, and document control processes.
• Experience operating within an ISO 13485 regulated environment strongly preferred.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.

Preferred Experience

• Medical device, pharmaceutical, biotechnology, or combination product industry experience.
• Exposure to electronic quality management systems (eQMS).
• Experience supporting audits and regulatory inspections.
• Knowledge of root cause analysis methodologies and risk assessment tools.

Key Skills

• Quality Assurance
• Batch Record Review
• GMP Compliance
• GDP Documentation
• Deviation Investigations
• CAPA Management
• Change Control
• SOP Authoring
• Material Release
• FDA Regulations
• ISO 13485
• Root Cause Analysis
• Document Control

Job Type & Location

This is a Contract position based out of Allendale, NJ.

Pay and Benefits

The pay range for this position is $26.00 - $28.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email View email address on click.appcast.io for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.