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

M1NYWlozS2YyUGJIWC84K3RyM0JyOHg3aUE9PQ==
  • 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

DHL

Warehouse Operations Specialist Job at DHL

 ...Join Our Team as a Warehouse Operations Specialist! At DHL, we are looking for dedicated individuals to fill the role of Warehouse Operations Specialist. As a vital part of our team, you will engage in various essential tasks that ensure our warehouse functions smoothly... 

Sport Clips

Hair Stylist Job at Sport Clips

Hair Stylist at Sport Clips summary: Sport Clips is hiring licensed hair stylists/barbers to provide mens and boys haircuts, offering above-average hourly pay plus daily cash tips, bonuses, benefits, PTO, and paid training. The role emphasizes customer service, building...

Cleveland Clinic

Cleveland Clinic Weston Hospital - Otolaryngologist - Head & Neck Surgeon Job at Cleveland Clinic

 ...Integrated Surgical Institute The Cleveland Clinic Integrated Surgical Institute invites applications for a board-eligible or board-certified Otolaryngologist / Head & Neck Surgeon to join our team at Cleveland Clinic Weston Hospital in Weston, Florida. About Our... 

Clayco

Landscape Architect 2 Job at Clayco

 ...to effect positive, enduring change. The Role We Want You For Lamar Johnson Collaborative (LJC) is looking to hire a Landscape Architect 2 (8+ years of experience) to join our landscape and planning practice team in Chicago or St. Louis. This position offers an... 

Hawaii Pacific Health

Medical Assistant - Mililani, Pediatrics Job at Hawaii Pacific Health

 ...Founded in 1921, Straub Benioff Medical Center includes a 159-bed hospital in Honolulu, a network of neighborhood clinics and...  ...services and routine immunizations. As a Medical Assistant in our Pediatrics department, you will join the dedicated team of physicians...