Quality Auditor - Scientific - II (Associate)

The Fountain Group; Rahway (NJ); Hybrid; USD 52,000 - 58,000; Part time

Job summary

The Fountain Group is seeking a Quality Assurance Specialist in Rahway, NJ, on a 23-month contract with a hybrid work arrangement. The role entails providing GMP‑compliant quality oversight for clinical‑stage drug product manufacturing, testing, and release, coordinating with cross‑functional teams to ensure regulatory compliance and continuous improvement.

The ideal candidate will have a Bachelor’s degree in a Science or Engineering field and at least 3 years of QA/QA‑Ops experience in

Qualifications

• Bachelor's degree in Science or Engineering required.
• Minimum 3 years’ experience preferred; recent grads considered.
• Experience in pharmaceutical/biotech/chemical/medical device industries.
• Experience in Quality Assurance, Quality Control, or Regulatory Affairs.
• Knowledge of cGMP, drug regulations, and regulated quality systems.
• Familiarity with R&D or clinical supply operations.

Responsibilities

• Support GDQ Ops quality oversight for manufacturing, testing, and release of clinical-stage products.
• Review batch records, CoAs, and quality documentation to determine product disposition.
• Perform QA activities including deviations, investigations, CAPAs, and audits.
• Ensure compliance with cGMP, ICH guidelines and internal policies.
• Communicate quality issues and risks to stakeholders; escalate when needed.
• Develop, write, and edit SOPs and GMP-controlled documents.
• Support quality system metrics and continuous improvement initiatives.
• Coordinate meetings and manage multiple quality review assignments.

Skills

Quality Assurance

GMP knowledge

Regulatory compliance

Quality documentation

Batch disposition

CAPA & investigations

Data analysis

Cross-functional collaboration

Risk management

Communication

Education

Bachelor's degree in Science or Engineering

Tools

SAP

Veeva

Job description

Details for the positionare as follows:

• 23 month contract to start with the possibility of extension or conversion depending on performance and business needs
• Rate: $39.27 an hour
• Location: Rahway, NJ
• Work Arrangement: Hybrid – 3 days onsite per week (Wednesdays required)
• Training: Fully onsite for approximately the first 3 months, transitioning to a hybrid schedule following training

Job Description:

• The Quality Assurance Specialist will support the Global Development Quality Operations (GDQ Ops) organization, providing quality oversight for manufacturing, testing, and release activities associated with clinical-stage drug products.
• This position plays an important role in ensuring GMP-compliant clinical supply operations for internally and externally manufactured products. Working closely with manufacturing, laboratory, quality, and other cross‑functional teams, the individual will support batch disposition, quality documentation review, regulatory compliance, and continuous improvement initiatives.
• Under the direction of GDQ Ops supervision, the specialist will perform a variety of quality assurance activities, including batch record review, product release, quality systems support, investigations, compliance, and document management, while ensuring adherence to current Good Manufacturing Practices (cGMP), ICH guidelines, and company policies and procedures.
• Perform independent quality review and approval of executed batch records, testing data, and supporting documentation to determine product disposition.
• Make independent batch release or rejection decisions in accordance with established procedures and regulatory requirements.
• Review Certificates of Analysis (CoAs) and associated quality documentation to ensure accuracy, completeness, and compliance.
• Support quality oversight of clinical drug product manufacturing, testing, and release activities.
• Complete assigned quality review activities within established deadlines while maintaining accuracy and attention to detail.
• Review, audit, and approve GMP‑regulated documentation, including deviations, investigations, analytical method validations, method transfers, analytical methods, specifications, and Certificates of Analysis.
• Support quality system activities, including corrective and preventive actions (CAPAs), compliance initiatives, and site audit readiness.
• Participate in quality risk management activities and identify potential compliance concerns.
• Ensure compliance with applicable GMP regulations, ICH guidelines, and internal quality policies.
• Communicate quality‑related issues, risks, and findings to appropriate stakeholders and escalated concerns when necessary.
• Develop, write, review, and technically edit Standard Operating Procedures (SOPs), quality procedures, and other GMP‑controlled documents.
• Maintain accurate and complete quality records, including cataloging documentation for long‑term storage in accordance with retention policies.
• Collect, prepare, and analyze data to support quality system metrics, operational planning, and continuous improvement initiatives.
• Participate in quality‑related projects and support process improvements across manufacturing and quality operations.
• Coordinate and facilitate meetings, document discussions, and communicate action items and project updates.
• Manage multiple quality review assignments and transition between different tasks while maintaining consistency, focus, and accuracy.
• Perform additional responsibilities as assigned to support the operational needs of the department.

Required Skills:

• Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology).
• Minimum of 3 years’ experience preferred. Recent graduate may be considered if not able to find experienced candidates.
• Experience should be in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry.
• Experience in one or more functional areas, including Quality Assurance, Quality Control, Laboratory Operations, Manufacturing, Production, Equipment/Facilities Management, or Regulatory Affairs.
• Knowledge of R&D or clinical supply areas and processes.
• Knowledge of current Good Manufacturing Practices (cGMP), applicable drug regulations, and regulated quality systems.
• Understanding of R&D or clinical supply operations and associated processes.

Preferred Qualifications & Experience

• Previous experience in Quality Assurance, quality auditing, batch disposition, or regulated manufacturing environments.
• Hands-on experience reviewing executed batch records, Certificates of Analysis, investigations, and other GMP‑controlled quality documents.
• Knowledge of drug product manufacturing, testing, and release processes.
• Experience within pharmaceutical, biologics, sterile manufacturing, or clinical drug product operations.
• Familiarity with production‑floor operations or QA-on-the-floor responsibilities.
• Experience supporting deviations, CAPAs, investigations, quality risk management, and regulatory compliance activities.
• Ability to handle multiple types of quality review assignments throughout the workday while maintaining accuracy.
• Working knowledge of SAP or comparable enterprise systems.
• Familiarity with Veeva or similar electronic quality and document management systems.