Deviations Investigator

　　Quality Assurance

　　Ocean County, NJ, US

　　Added - 15/01/2024Apply for Job

　　Our pharmaceutical client in Ocean County, NJ is seeking a Quality Assurance Investigator for their team. The QA Investigator will be responsible for conducting investigations to ensure compliance with cGMPs and SOPs.

　　Location: Ocean County, NJ

　　Pay: $68,000-$73,000 per year

　　Type: Direct hire

　　Responsibilities

　　Own, lead, and support prompt, thorough, and well-written investigations assuring that root cause evaluations are performed in compliance with cGMPs and associated SOPs.

　　Utilize technical writing strategies to ensure content is clear, concise, and complete.

　　Drives investigations to timely closure through collaborative efforts with Operations, Quality Assurance, Engineering, and other functional areas, as needed.

　　As needed, utilize investigational RCPS tools like 6M, Fishbone, and 5 Why’s to deliver thorough investigations.

　　Observe activities on the manufacturing floor and engage with Process Owners to gain the process knowledge needed to deliver technically sound investigations.

　　Work with the area owners to identify the most probable root cause(s) and determine appropriate preventive and corrective actions.

　　Discuss investigations as required with regulatory agencies, quality assurance, or clients, as required

　　Works independently and is flexible to changing priorities.

　　Supports and maintains an environment that fosters communication and teamwork within the Operations Group and other departments.

　　Qualifications

　　Bachelor's degree in Science/Engineering with a minimum of 3 years of relevant experience in the pharmaceutical industry.Experience with cGMP software is preferred.

　　We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.