Deviation Investigator, Manufacturing

Company: Renaissance LLC
Location: Lakewood
Posted on: February 21, 2021

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.

Overview

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

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

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.

PI

Keywords: Renaissance LLC, Lakewood , Deviation Investigator, Manufacturing, Other , Lakewood, New Jersey