QA Auditor

Job Description

Job Description

Job Title: QA Auditor

Job Description

The Quality Assurance Auditor supports first shift operations from 9:00 a.m. to 7:30 p.m. by performing critical inspection and auditing activities that ensure products meet stringent quality and regulatory standards. This role focuses on line coverage, audit reviews, monitoring charts, and completing all required documentation and data entry related to quality assurance monitoring in a highly regulated manufacturing environment.

Responsibilities

• Perform comprehensive line checks, including in-process testing, component verification, barcode operation verification, sample review, aseptic monitoring, and end-item inspection to ensure products meet quality and compliance standards.
• Complete line clearance inspections and review area logs for proper documentation prior to lot processing to confirm readiness and compliance before production begins.
• Check in all components prior to their use in production, verifying accuracy, status, and suitability for use.
• Review and approve production records and associated production paperwork prior to issuance, ensuring all calculations and entries are accurate and complete.
• Conduct chart reviews, log reviews, product reviews, and document reviews to verify adherence to procedures, specifications, and regulatory requirements.
• Perform batch record reviews for accuracy and compliance with company procedures and current Good Manufacturing Practices (cGMP).
• Oversee the documentation of production interventions as needed, ensuring timely, accurate, and compliant recording of events.
• Execute area purges in packaging and/or vial wash areas to maintain a controlled and compliant environment.
• Perform shelf reserve sampling, reviews, technical review reports (TRRs), and related documentation to support product quality and stability programs.
• Successfully complete and maintain Manual Inspection Qualification for vial inspections and apply this qualification in daily inspection activities.
• Attend meetings as required or requested to provide quality input, share findings, and support cross-functional collaboration.
• Promote a safe and harmonious work environment by modeling safe behaviors and encouraging teamwork and mutual respect.
• Maintain strict compliance with standard operating procedures (SOPs), Good Manufacturing Practices (GMPs), and all company policies.
• Use quality and compliance vigilance to proactively identify, escalate, and help resolve potential issues in production and documentation.
• Apply critical thinking and advanced problem-solving skills to evaluate quality issues and recommend appropriate corrective and preventive actions.
• Provide coaching and feedback by inspecting the work of others and guiding performance in line with company SOPs and quality expectations.
• Effectively articulate and present the organization’s quality strategy to employees, management, regulatory bodies, and customers as needed.
• Support and lead by example while working with minimal supervision, demonstrating professionalism, ownership, and accountability.
• Perform other duties as assigned or required to support overall quality assurance and continuous improvement efforts.

Essential Skills

• Associate degree in a science or related field from a regionally accredited institution.
• At least 1 year of quality assurance experience in a pharmaceutical or other highly regulated industry.
• Knowledge of quality auditing practices and their application in a regulated manufacturing environment.
• Knowledge and understanding of processes relevant to quality compliance in the manufacturing and production of regulated products.
• Knowledge of regulatory cGMP requirements for pharmaceuticals and regulatory entity inspection requirements.
• Familiarity with regulatory guidance documents and applicable audit schemes.
• Proficiency with general computer functions, including Microsoft Office programs and spreadsheets.
• Skill in handling several projects or tasks simultaneously or within defined time frames.
• Advanced problem-solving skills and the ability to apply critical thinking to complex quality issues.
• Safety sensitivity and the ability to recognize safety issues or potential safety issues in the work environment.
• Effective time management skills for personal tasks and coordination of activities involving others.
• Skill in maintaining quality and compliance vigilance in day-to-day operations.
• Ability to inspect the work of others and coach performance in alignment with standard operating procedures.
• Advanced interpersonal and communication skills, both verbal and written.
• Ability to clearly articulate and present quality strategies to diverse audiences, including employees, leadership, regulatory bodies, and customers.
• Ability to be flexible in work hours to support operational and quality needs.
• Ability to maintain a professional, positive attitude at all times, even under pressure.
• Advanced project management and documentation skills to manage quality-related initiatives and records.
• Ability to use training and instructional methods and procedures appropriate for different situations and audiences.
• Ability to instruct and teach individuals one-on-one on how to perform quality-related functions.
• Ability to develop, maintain, and strengthen partnerships with colleagues across the organization to obtain information, assistance, and support.
• Ability to work with minimal supervision and to lead by example in promoting quality and compliance.

Additional Skills & Qualifications

• Experience working in pharmaceutical, biotechnology, or similarly regulated production environments.
• Experience participating in or supporting internal and external audits.
• Demonstrated ability to provide motivational support and encourage high performance within teams.
• Experience presenting or supporting interactions with regulatory bodies and customers on quality-related matters.
• Experience using documentation systems and electronic tools to manage quality records and audits.
• Strong attention to detail and accuracy in reviewing production records, logs, and charts.
• Demonstrated ability to collaborate effectively in cross-functional teams, including production, quality, and support functions.

Work Environment

The role operates primarily in clean room, laboratory, and production environments within a highly regulated facility. The QA Auditor works on a first shift schedule from approximately 9:00 a.m. to 7:30 p.m., supporting active manufacturing and packaging operations. Work involves frequent presence on production lines, in clean rooms, and in lab areas to perform inspections, monitoring, and audits. The position requires adherence to strict Good Manufacturing Practices and standard operating procedures, including compliance with clean room protocols and use of appropriate protective attire and gowning where required. The environment is fast-paced and detail-oriented, with regular interaction with production staff, quality professionals, and other departments to ensure consistent product quality and regulatory compliance.

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

The pay range for this position is $24.00 - $30.00/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)

This is a fully onsite position in Syracuse,NY.

This position is anticipated to close on Sep 24, 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 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.