Quality Auditor - Scientific - II (Assoc...

Quality Assurance Specialist – Clinical Supply Operations

Education and Experience

Bachelor’s degree in an appropriate Science or Engineering discipline, such as Engineering, Chemistry, Biology, Biochemistry, or Microbiology.

Minimum of 3 years of relevant experience preferred.

Recent graduates may be considered if experienced candidates are not available.

Experience in the pharmaceutical, biotechnology, chemical, medical device, or a closely related regulated industry.

Knowledge of research and development and/or clinical supply areas and processes.

Drug product manufacturing and testing knowledge and experience preferred.

Experience in one or more functional areas such as: Quality Control

Quality Assurance

Laboratory operations

Manufacturing

Production

Equipment or facilities management

Regulatory

Knowledge of Good Manufacturing Practices (GMP) or related pharmaceutical regulations.

Strong leadership, collaboration, teamwork, negotiation, communication, and workload-management skills.

Ability to work in a dynamic R&D environment with rapidly changing priorities.

Demonstrated ability to manage projects and priorities while meeting established deliverables and timelines.

Ability to work across functions and sites and with employees at all levels of the organization.

Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Teams.

Ability to learn and adapt to additional electronic systems used to support daily work.

Key Skills

Batch disposition

Executed batch-record review

Quality assurance in a regulated manufacturing environment

Certificate of Analysis review

Investigation and quality-document review

Production-floor or QA-on-the-floor knowledge

Strong attention to detail

Ability to concentrate for extended periods

Ability to complete assignments from beginning to end

Accuracy when moving between different types of work

Problem-solving and sound judgment

Initiative and appropriate escalation of questions

Clear communication of risks and issues

Cross-functional collaboration

Microsoft Excel, Word, and PowerPoint

SAP knowledge

Veeva familiarity

Ability to learn organization-specific systems, processes, and terminology

Preferred Experience

Previous quality auditing, quality assurance, or batch disposition experience.

Experience reviewing executed batch records and regulated quality documents.

Experience in pharmaceutical, biologics, sterile manufacturing, or another regulated industry.

Production-floor or QA-on-the-floor exposure.

Experience reviewing investigations and Certificates of Analysis.

Experience handling multiple types of quality review assignments during the same workday.

Familiarity with SAP or a comparable enterprise system.

Scientific or engineering education.

For recent graduates, demonstrated technical aptitude, focus, initiative, problem-solving skills, and willingness to complete extensive training.

Work Arrangement

Fully onsite during the training period.

After training, the role will transition to a hybrid schedule requiring 3 days onsite per week.

Wednesday is a required onsite day.

Work location: Rahway, New Jersey.

Candidate Preferences

Experienced candidates should be prioritized.

Recent graduates may be considered if the experienced-candidate pool is limited.

Engineering graduates are preferred, although Biology, Chemistry, and other scientific degrees may also be considered.

Candidates with master’s degrees may be considered if their experience aligns with the role.

Training

The first approximately three months will focus heavily on training.

Training will consist of approximately: 40% self-paced computer-based learning

60% hands-on learning

A trainer or assigned team member will guide the contractor.

Training activities will include observing meetings, learning internal terminology, completing qualification activities, and demonstrating required skills before working independently.

Some qualification activities must be completed onsite.

Typical Responsibilities

Review post-executed batch records.

Review Certificates of Analysis and related quality documentation.

Review investigations and supporting records.

Complete defined assignments within established deadlines.

Move between different quality-review activities while maintaining focus and accuracy.

Position Overview This role provides Quality oversight for manufacturing, testing, and release activities associated with clinical-stage drug products. The position supports product development activities in collaboration with operations and cross-functional partners while helping ensure continuous GMP-compliant clinical supply for internally and externally manufactured products. Under the direction of Quality leadership, the contractor will provide quality assurance oversight, perform diverse quality-related tasks, and participate in quality projects. Responsibilities may include product release, quality systems, compliance, document management, and related activities performed under current Good Manufacturing Practices. The contractor will help ensure compliance with applicable GMP regulations, ICH guidelines, policies, and procedures.

Key Responsibilities

Perform independent quality review and approval of batch records, testing data, and related d