Manufacturing Investigations Lead

Location: Buena, NJ

Job Summary

The purpose of this position is to serve as the primary investigator for the Operations Group to ensure timely and accurate completion of manufacturing investigations, implementation of subsequent corrective actions, and completion of manufacturing change controls.  This will be accomplished largely through conducting appropriate root-cause analysis for events and authoring investigations reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products.

This person is expected to work under minimal supervision. Work is reviewed upon completion for adequacy in meeting objectives.

Essential Responsibilities

  • Lead and/or support prompt and thorough investigations assuring that thorough root cause evaluations are performed in compliance with cGMPs and associated SOPs and ensures timely closure for each investigation as well as follow-up activities.
  • Work with the functional areas to identify the most probable root cause(s) and determine appropriate preventive and corrective actions.
  • Trend and analyze investigation data and address appropriately in cooperation and collaboration with other support functions such as Quality and Engineering.
  • Supports and maintains an environment that fosters communication and teamwork within the Operations Group and other departments.
  • Write technical documents to support operations including SOPs and batch records.
  • Train and mentor less qualified employees in the department. This includes but is not limited to processes, procedures in compliance with established protocols and regulatory guidelines.
  • Maintain current knowledge of cGMPs through appropriate training programs.
  • Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance.
  • Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
  • Exemplify the DPT Core Values of Integrity, Dignity, Perseverance and Trust.

MAY PERFORM ALL OR SOME OF THE FOLLOWING DUTIES :  

  • Troubleshooting and Improvement to Processes using standard Engineering methods and standards
  • Create and maintain forms, logbooks, and setup sheets for equipment used in manufacturing processes
  • Maintain and support inventory control in support of production operations
  • Create Capital Requests and purchase requisitions to support production departmental projects

Qualifications

  • Bachelor’s degree, and a minimum of 3 years of bench/ technical related experience.
  • Experience authorizing investigations that cover Out of Specification (OOS) and Out of Trend (OOT) results.
  • Exceptional writing and communication skills that can clearly convey investigational findings.
  • Strong critical thinking and deductive reasoning skills.
  • Excellent interpersonal and communications skills.
  • Must be able to interface positively with Regulatory Agencies and company departments.
  • Demonstrated ability to work on multiple projects and meet tight timelines.
  • Knowledge of cGMP requirements.
  • Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
  • Confident person with excellent organizational skills.
  • Collaborative working style that can get along with diverse personalities.
  • Demonstrates a high level of professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.

Physical Demands/Factors

  • While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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