Quality Auditor Scientific II (Associate)

Global Development Quality Operations Drug Product (GDQ Ops)

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 recent graduates 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.
Recent graduates 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 masters 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.

Nesco Resource offers a comprehensive benefits package for our associates which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical Vision Dental 401K and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.

Required Experience:

IC