Deviation Investigator
Company: Renaissance LLC
Location: Lakewood
Posted on: January 15, 2021
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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
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 actionsThis 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 overtimeResponsibilities--- 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.QualificationsBachelor'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.PI127909815
Keywords: Renaissance LLC, Lakewood , Deviation Investigator, Other , Lakewood, New Jersey
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