Deviation Engineering

Company: System One
Location: Lakewood
Posted on: June 19, 2022

Job Description:

Title: Deviation Investigator (Quality Assurance)
Location: Lakewood, NJ
Schedule: Monday - Friday (8am-5pm)
Type: Direct Hire
Start date: ASAP

Responsibilities:
The purpose of the Deviation Investigator, Manufacturing, is to serve as a primary investigator for the Operations Group to ensure timely and accurate completion of high-quality manufacturing investigations and implementation of subsequent corrective actions. This will be accomplished largely through leading and conducting appropriate root-cause analyses for events and authoring investigation reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products. 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
Utilize excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk. Must be resourceful, self-reliant, self-motivated, and confident.
Works independently and is flexible to changing priorities. Strong personal computer skills. Must have excellent teamwork and organizational skills.
Supports and maintains an environment that fosters communication and teamwork within the Operations Group and other departments.
Exemplify the Renaissance Core Values of Integrity, Dignity, Perseverance and Trust.



Requirements: Bachelor's degree in Science/Engineering with a minimum of 3 years of relevant experience in the pharmaceutical industry or additional education in project or documented investigational course work may be substituted for experience on a per year basis .
Bachelor's degree in engineering or science field preferred.
Experience with cGMP software such as Trackwise preferred.
Experience with investigational RCPS (Root Cause Problem Solving) tools like 6M, Fishbone, and 5 Why's to deliver thorough investigations.
The ability to read, write and speak English is a requirement of the job.



Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Lakewood , Deviation Engineering, Engineering , Lakewood, New Jersey