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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Location: RTP NC
  • Source: Business
  • Ad #: 15430
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Kelly Services is currently looking to hire an experienced Manufacturing Investigator to support our client, a leader in the biotechnology industry, at their site in RTP, NC. This is a 12+ month contract with potential for extension. APPLY NOW if interested!

The Manufacturing Investigator will support activities in regards to Deviations and Optimization Projects. An understanding of investigation root cause analysis, investigation writing techniques, manufacturing processes and its equipment, and a practical knowledge of current regulations and cGMPs are needed to perform this position effectively.

RESPONSIBILITIES:

  • Follow site procedures and comply with cGMPs
  • Complete daily activities and ensure all timelines are maintained and met
  • Lead investigations for non-conformances which include deviations, environmental excursions and equipment remedial action activities
  • Participate in site improvement projects related to GMP manufacturing functions
  • Investigate non conformances to determine causal factors and corrective and preventative action. Work with operations leadership and Quality to facilitate investigations for deviations including environmental excursions and RARs. Deliver investigation write ups and appropriate CAPAs in accordance to GMP standards within required timelines. Facilitate knowledge transfer regularly throughout the investigation process. Apply Human Performance principles to investigation writing and root cause analysis.
  • Participate in improvement projects and effective strategies for site implementation. Coordinate and track deliverables for project implementation. Monitor schedule and actively monitor project timelines. Identify areas of risk and issues. Communicate updates to management and key stakeholders.

REQUIREMENTS:

  • Bachelor’s degree with 2 years related experience OR Associate’s degree with 3 years related experience.
  • General knowledge of investigation writing.
  • Intermediate skills in Microsoft Office.
  • Good understanding of cGMPs and regulations.
  • Knowledge of upstream and downstream manufacturing.
  • Intermediate level of technical writing skills.
  • Ability to interpret documents that support GMP manufacturing (work orders, drawings, batch records, etc.).
  • Working knowledge of enterprise systems (Trackwise, Agile, Labware, etc.).
 
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