Quality Auditor - Scientific - II (Associate)

Global Development Quality Operations – Drug Product (GDQ Ops)
CONTRACTOR POSITION
Education and Experience:
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.
Knowledge of R&D or clinical supply areas and processes.
Preferred drug product manufacturing and testing knowledge and experience.
Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, regulatory.
Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise.
Strong leadership, collaboration, teamwork, negotiation, communication, and workload management skills.
Ability to work in a dynamic R&D environment with rapidly changing needs.
Demonstrated ability to manage projects, priorities, to meet deliverables and timelines.
Ability to work across functional and sites, with all levels of staff and management.
Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day 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 company-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
Pharmaceutical, biologics, sterile-manufacturing, or other regulated-industry experience
Production-floor or QA-on-the-floor exposure
Experience reviewing investigations and Certificates of Analysis
Experience handling different quality-review assignments during the same workday
Familiarity with SAP or a comparable enterprise system
Scientific or engineering education
For entry level candidates, evidence of technical aptitude, focus, initiative, problem-solving, and willingness to complete extensive training
Notes:
Fully onsite during training period, transitioning to Hybrid role requiring 3 days onsite a week.
(3 days/week onsite-Wednesday is must to be onsite)
Wokr Location: Rahway, NJ
Candidate preference:
Experienced candidates should be prioritized.
entry level candidates may be considered if the experienced-candidate pool is limited.
Engineering graduates are preferred, although biology, chemistry, and other scientific degrees may 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 be about 40% self-paced computer-based learning and 60% hands-on learning.
A trainer or assigned team member will guide the contractor.
The contractor will observe meetings, learn company terminology, complete qualification activities, and demonstrate 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 review activities while maintaining focus and accuracy.
The GDQ Ops organization provides Quality oversight for manufacturing, testing, and release activities associated with clinical-stage Drug Products. We provide Quality oversight of product development activities integrated with operations and functional partners, while ensuring continuous GMP-compliant clinical supply for internally and externally manufactured clinical supplies.
Under the direction of GDQ-Ops Supervision, the Contractor will be responsible for providing quality assurance oversight, performing diverse tasks, and participating in quality related projects. Responsibilities include the following activities in a support role: product release, quality system, compliance, document management, and any related activities needed under current Good Manufacturing Practice (cGMP). Ensure compliance with applicable GMP regulations, ICH guidelines, *** policies, and procedures.
The Contractor will support tasks that may include but are not limited to:
Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions.
Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
Collect, prepare and analyze data to support quality system metrics and planning.
Perform document management activities such as cataloging records for long term document storage according to retention policies.
Support compliance activities such as site readiness, audits, and CAPAs.
Support quality risk management activities.
Support projects for continuous quality improvement. Utilize project management skills as needed.
Provide meeting coordination, facilitation, scribing, and communication.
Develop, write, technical edit, or review procedures or other standards documents under GMP.
Other duties as assigned by manager for the flexible functioning of the work group.