Compliance Investigator, Clinical Manufacturing Job at Lynkx Staffing LLC, Saddle Brook, NJ

V3F5UWtFcml4UEgzYlhtYkF0K3d1cDNoUEE9PQ==
  • Lynkx Staffing LLC
  • Saddle Brook, NJ

Job Description

Job Description

Job Description

Compliance Investigator, Clinical Manufacturing Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing 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.

  • 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.
REQUIREMENTS
  • BS degree 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.
  • 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
  • Flexible and able to adapt to company growth and evolving responsibilities
  • Integrity, accountability and strong dedication to regulatory compliance
  • Continuous improvement mindset
  • Ability to work effectively as a team and independently.
  • Quality Systems Training (Deviation/CAPA)
Working 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. 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 cryo-gloves must be used when working with liquid nitrogen. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Tags

Flexible hours,

Similar Jobs

4th Day Trucking

SEMI LOCAL CLASS A DRIVER ! ADVANCED AUTO ACCOUNT hazmat n 12 months exp 5 k bonus Job at 4th Day Trucking

 ...SEMI LOCAL ! This means 2 lay overs a week. OFF WEEKENDS! ADVANCED AUTO PARTS ACCOUNT! 12 months exp required! HAZMAT NEEDED! Night shift ! Must have a clean record!NO SAP DRIVERS ! Pays 1600 to 1700 plus a week 5 k bonus to start! Highlights: Daily Home... 

Torch.AI

Junior Software Engineer, Intelligence & Operations (Java) Job at Torch.AI

 ...of the Torch.AI Journey! Torch.AI is a defense focused AI software company. Unlike traditional government contractors, our team...  ...Human Potential. The Role: Unlock Your Potential As a Junior Software Engineer, Intelligence & Operations at Torch.AI, you will be at the... 

Billings Clinic

Executive Director - Chief Data Officer (, MT, United States) Job at Billings Clinic

 ...employees must complete several pre-employment requirements prior to starting. Click here to learn more! Executive Director - Chief Data Officer PMO / OPERATIONS - 100.8732 (BILLINGS CLINIC N 27TH ST BUILDING) req10136 Shift: Day Employment Status: Full-Time... 

Compunnel Inc.

IBM Mainframe/COBOL developer - Remote Job at Compunnel Inc.

 ...DE (Weekly 5 days office) Duration: Long Term Contract JD: Design, code, test, and maintain mainframe applications using COBOL, JCL, DB2, IMS DB/DC, CICS, VSAM, and IBM MQ. Develop and support batch and online processes, including job streams, transaction... 

China Global Connections

University English Teacher Job at China Global Connections

 ...English to university students (18 - 22 years old),focusing on speaking, language skills, literature, and effective...  ...benefitsMonthly salary of 12,000 - 14,000 RMBFree independent apartmentHoliday AllowanceFlight AllowanceInsuranceFree Chinese Language Courses