Deviation Investigator, Manufacturing
Company: Renaissance LLC
Posted on: January 13, 2021
Renaissance LLCAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.
The Deviation Investigator, Manufacturing will 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.
This position is exempt from overtime
--- 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
--- 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
--- Works independently and is flexible to changing priorities.
Strong personal computer skills. Must have excellent teamwork and
--- Supports and maintains an environment that fosters
communication and teamwork within the Operations Group and other
--- Exemplify the Renaissance Core Values of Integrity, Dignity,
Perseverance and Trust.
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.
Keywords: Renaissance LLC, Lakewood , Deviation Investigator, Manufacturing, Other , Lakewood, New Jersey
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