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