Deviation Investigator, Manufacturing
Company: Renaissance LLC
Location: Lakewood
Posted on: August 7, 2022
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Job Description:
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.OverviewThe 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. his 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.The ability to
read, write and speak English is a requirement of the job.
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---
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.Qualifications
Keywords: Renaissance LLC, Lakewood , Deviation Investigator, Manufacturing, Other , Lakewood, New Jersey
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