About The Position

Provides technical direction and supervision in an assigned biological production area in accordance with company policies and corporate business plans. Ensures workforce technical competence through appropriate selection and training, maintains a safe workplace, and implements and maintains compliance with cGMP and OSHA requirements. Manages production-floor documentation, including batch records and equipment logbooks. Supports a continuous-improvement philosophy, implements new technologies, and helps maintain low production costs. The role supervises and develops personnel; coordinates departmental activities and schedules; manages budgets, expenses, capital projects, supplies, equipment recommendations, and inventory cycle counts. It manages production documentation and key performance indicators, reviews and approves relevant procedures and controlled documents, analyzes production issues and trends, investigates deviations, and implements corrective solutions. The Process Leader also directly participates in, supervises, and supports production process execution to ensure safe, compliant, and reliable outcomes. This position is scheduled Monday through Friday, 3:00 PM to 11:30 PM.

Requirements

  • High school diploma.
  • At least 2 years of professional experience in addition to a bachelor's degree, or 6 years of relevant experience in lieu of a degree.
  • At least 1 year of leadership experience, included in the required experience.
  • Ability to train others and complete on-the-job training (OJT) assessments.
  • Ability to follow systematic continuous-improvement methodologies and willingness to identify, define, and implement process improvements.
  • Experience managing and auditing master receipts, batch records, and process-order data in relevant SAP/ERP software systems.
  • Experience with word processing, spreadsheets, and database management.
  • Proficient in Microsoft Office applications, including Word, Excel, and Outlook.
  • Detail-oriented, able to work with minimal supervision, and self-motivated in using resources to troubleshoot as needed.
  • Ability to manage multiple ongoing projects with aggressive deadlines.
  • Strong proofreading skills and excellent written and verbal communication capabilities.
  • Ability to learn and quickly become proficient in software applications used for packaging equipment and operations.
  • Legally authorized to work in the United States without restriction.
  • Willingness to take a drug test and post-offer physical, if required.
  • At least 18 years of age.

Nice To Haves

  • Bachelor's degree in a related business or scientific field.
  • Experience with ERP inventory control systems.

Responsibilities

  • Supervise personnel and communicate departmental status, progress, concerns, issues, employee actions, ideas, and other relevant information to management.
  • Hire, train, coach, and develop personnel in accordance with policies and procedures.
  • Coordinate departmental activities and schedules.
  • Prepare or manage the departmental budget and monitor expenses and capital projects.
  • Purchase operating supplies and recommend new or replacement equipment.
  • Coordinate departmental cycle counts to control production-area inventory.
  • Organize and prioritize batch-record reviews for completed production items as directed by management.
  • Create, review, and approve relevant SOPs, controlled forms, and other business-function documents supporting regulatory compliance, change controls, and company initiatives.
  • Manage and maintain the department's key performance indicator tracking system.
  • Provide management with data and metrics on individual, equipment, and production trends, and recommend solutions to resolve errors.
  • Analyze production problems, document findings, and implement solutions.
  • Investigate production process deviations.
  • Ensure production-process compliance with cGMP, APHIS, OSHA, EPA, EU, and JP regulations.
  • Perform, supervise, and support production process steps to ensure safe, compliant, and reliable outcomes.
  • Maintain production-floor documentation, including batch records and equipment logbooks.
  • Support continuous improvement, implement new technologies, and help maintain low production costs.

Benefits

  • Competitive compensation and benefit programs.
  • Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance.
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