Operations Investigation Writer Job at Leiters Inc in Englewood

General Description:

This position reports to the department management.  The Operations Investigation Writer is the primary investigator for the Operations Group to ensure timely and accurate completion of manufacturing deviation investigations, implementation of subsequent corrective actions, and completion of manufacturing change controls. This will be accomplished largely through conducting appropriate root-cause analyses for events and authoring investigations reports related to compounding, filling, visual inspection, and packaging of sterile pharmaceutical products.

Essential Functions and Responsibilities:

• Lead and 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 Leiters Health Core Values of Integrity, Honesty, Perseverance and Trust.

Experience and Necessary Skills:

• Bachelor's degree with a minimum of 2 years of relevant experience in the pharmaceutical industry. Additional education may be considered in lieu of experience.
• Knowledge of cGMPs and GDPs
• Ability to work with mathematical concepts such as probability and statistical inferences to practical situations.
• Ability to read, write, and comprehend English
• Detail oriented
• Ability to lift up to 50 lbs. and stand for extended periods when required