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Serán BioScience

Posted 22 days ago

Operations Supervisor (Swing Shift)Serán BioScience · Bend

Operations Supervisor (Swing Shift)

BendOn-site

AI Summary

Oversees swing shift activities in spray dry dispersion manufacturing, directing daily workflow, assigning tasks, and ensuring GMP compliance and SOP adherence.

About this role

Serán is expanding the Spray Dry Manufacturing Operations capabilities into a swing shift to support daily activities for the Operations Department. This Operations Supervisor will oversee swing shift activities according to established procedures focusing on spray dry dispersion manufacturing schedule. This position is responsible for ensuring a high level of compliance with internal SOPs and regulatory guidance. The Operations Supervisor assigned to swing shift will direct the daily workflow of the department, assign tasks to Operations team members, and ensure projects are completed to GMP standards and specifications of SOP with a focus on suite cleaning and material dispensing. Operations Supervisor is responsible for independent problem solving and expressing good judgement in decision making and knowing when it is appropriate to escalate concerns. Those with SDD experience in a GMP manufacturing environment who aspire to lead and motivate others are encouraged to apply.

Duties and Responsibilities

  • Oversee small production team and daily shift activities
  • Follow strict standard operating procedures (SOPs)
  • Write and review standard operating procedures
  • Weighs, measures, subdivides, and disposes of components
  • Safely handle hazardous materials
  • Participate in audits or inspections
  • Inspects and maintains equipment
  • Draft, review, and approve quality records as technical approver
  • Subject matter expert for operations
  • Conduct and attend training activities
  • Completes documentation, including logbooks and batch production and control records
  • Works closely and communicates effectively with operations team
  • Responsibilities may increase in scope to align with company initiatives
  • Performs other related duties as assigned

    • Required Skills and Abilities

  • Mechanical aptitude
  • Intermediate math skills
  • Strong verbal and written communication skills  
  • Strong organization skills and attention to detail  
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Proficient math and problem-solving skills  
  • Strong time management skills with ability to meet deadlines  
  • Ability to prioritize and ask for assistance to delegate tasks when appropriate  
  • Ability to focus in a fast-paced environment with shifting priorities  
  • Proficient with Microsoft Office Suite or related software  

    • Education and Experience

  • High school diploma or equivalent
  • Demonstrates history of leadership abilities
  • Proficient in Oral Solid Dosage and Spray Dry equipment and GMP processing
  • Requires a minimum of 2 year of GMP experience

    • Physical Requirements

  • Prolonged periods of sitting or standing while monitoring equipment
  • Must be able to lift up to 25 pounds regularly, and up to 55 pounds occasionally
  • Require ability to work swing shift with the possibility of 12-hour shifts
  • Must be able to wear a Tyvek suit with PAPR for extended periods of time 
  • Exposure to constant low-level equipment noise, and occasional high-level alarms 
  • Work near heat generating equipment
  • Must be able to operate a forklift, training provided  
  • Move up and down ladders, kneel, squat and lift from the floor  
  • Move mop above head while cleaning room surfaces
  • Adheres to consistent and predictable in-person attendance

    • Skills

    Batch Production RecordsEquipment Inspection And MaintenanceForklift OperationGMPHazardous Materials HandlingMaterial DispensingMicrosoft OfficeOral Solid DosageQuality RecordsSpray Dry Dispersion (SDD)Standard Operating Procedures (SOPs)Suite Cleaning

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