Compliance Investigator job in Allendale
|Employer:|| Hitachi Chemicals Advanced Therapeutic Solutions|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Allendale, NJ 07401, USA (Show on map)
We are seeking a highly motivated Compliance Investigator who is interested in joining our fast-paced, dynamic environment.
Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. This position is based in Allendale, NJ.
Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.
Drive investigations to true root cause using appropriate investigation tools.
Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
Define and implement effective preventative actions to prevent recurrence.
Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
Collaborate with cross-functional teams to develop and track CAPA plans.
Identify and create appropriate trending rules that trigger corrective actions.
Analyze process data and evaluate trends to identify major improvement opportunities.
Effectively utilize change management approach.
Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process.
Champion CAPA plans and implementation.
Provide communication plan for on-going deviations & CAPA’s.
Effectively create and communicate CAPA plan to responsible parties.
Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
Ability to abide by quality standards.
Work Environment: While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is regularly required to climb or balance; stoop, kneel, or crouch. The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance). Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryogloves must be used when working with liquid nitrogen.
Knowledge & Experience:
Bachelor of Science in a Quality / Process related field.
Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma.
Root cause analysis experience in pharmaceutical or FDA regulated operation preferred.
Experience using e-Quality Management Systems preferred.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
Analytical and problem-solving skills
Strong written and oral communication skills
Meeting management/facilitation skills/teamwork
Ability to multi-task team is essential
Flexible and able to adapt to company growth and evolving responsibilities
Drive to create and maintain order in a fluid technically complex environment
Integrity, accountability and strong dedication to regulatory compliance
Continuous improvement mindset
Ability to work effectively as a team and independently.
Hitachi Chemical Advanced Therapeutics Solutions, LLC (formerly PCT Cell Therapy Services, LLC), is an industry leader in contract development and manufacture of cell therapy products. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, full scale cGMP/GLP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support.
Our mission is to provide our clients with high quality, scalable, innovative, reliable, and cost efficient manufacturing platforms and services to advance commercialization of cellular therapies. We are in the business of developing innovative service products for cell therapy manufacture; selling these to senior leaders in charge of development programs in collaboration with their subject matter experts; and delivering these service products for the development and execution of cell-based therapy manufacturing directly to clinical and commercial development teams around the world.