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Manufacturing Operations Manager

2 months ago


Petersburg, United States Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to affordable, high-quality medications.

Job Description

The Manufacturing Supervisor will play a critical role in the facility start-up at our Civica Petersburg, VA site. This position will lead day-to-day Cartridge Visual Inspection and Pen Assembly Operations, overseeing and running equipment, supporting new product introductions, equipment qualifications, change management, investigations, training, and development.

Key Responsibilities:
  • Lead the Pen Assembly and Visual Inspection team to execute daily and weekly production schedules to meet operations objectives.
  • Conduct daily shift meetings to communicate current events, issues, and solicit team feedback.
  • Monitor team productivity and resolve immediate production needs to facilitate efficiency.
  • Manage daily and weekly staffing requirements to account for absent personnel (PTO) to satisfy production needs.
  • Monitor the inventory of department supplies and report any quality issues or shortages to prevent production interruptions.
  • Conduct training and ensure staff training is documented, current, and follows cGMP requirements.
  • Review batch records, cycle reports, and other manufacturing documentation to identify and address any potential quality issues.
  • Perform and/or oversee batch accountability calculations and final batch quantity confirmations.
  • Provide immediate support in the identification and documentation of deviations and discrepancies.
  • Support cross-departmental activities including maintenance, qualification, testing, and investigational activities.
  • Assist in the development and update of manufacturing procedures and training materials.
  • Perform other duties as assigned by manufacturing management.
Requirements:
  • Associate degree with 8+ years demonstrated ability in a cGMP production environment.
  • High School degree with 10 years of experience in cGMP production may be considered.
  • Experience in a sterile fill finish facility.
  • 2+ years of supervisory experience.
  • Strong writing and documentation skills.
  • Ability to perform mathematical calculations that include exponents, scientific notation, orders of operation, algebra, and unit conversion.
  • Proficiency in Microsoft Office applications.
Preferred Qualifications:
  • Experience with Pen Assembly and/or Visual Inspection strongly preferred.