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Resilience · 2 days ago

Supervisor, Quality Control Microbiology Laboratories

West Chester, OH

Full-time

Onsite

Mid, Senior Level

$75K/yr - $116K/yr

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Supervisor, QC Microbiology Labs is responsible for microbiology laboratory quality control of pharmaceutical manufacturing, managing a team, and ensuring compliance with quality standards.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

Ensures that systems and processes owned by their team are in a state of control and are effectively managed and maintained

Assigns responsibilities to ensure that workload is managed within their team, ensuring effective use of resources

Assigns and manages roles and responsibilities within their team to ensure clear accountabilities and high-level performance, that meet or exceed customer needs

Allocates team staffing and manages the utilization of resources to ensure that departmental objectives are met within budget guidelines

Maintains a safe work environment by ensuring that team personnel follow site EHS policies and procedures

Develop and maintain a high performing team of Senior Microbiologists, Microbiology Analysts, and Microbiology Technicians

Coordinates workflow within their QC team. Directs priorities and testing schedules for staff

Utilizes Lean concepts to drive improvements

Train others on procedures and/or processes

Review, verify, and approve QC data while monitoring for trends and abnormalities. May author technical trend reports

May serve as QC lead for investigations involving PET process areas related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling and testing

Support transfer, development and qualification of new methods and processes

Identifies and implements learning and development programs for team members

Ensures that team skills, knowledge, and experience are appropriate and well balanced to meet team needs

Provides feedback to their team, and to other teams that interact with team, to assist with building improved performance

Answer compliance and process questions from others, including regulatory agencies

Communicate policies and procedures to employees

Lead process improvement activities and teams to meet strategic goals including Lean labs and High Performing Labs

Communicate priorities and progress to team on a continuing basis

Ensure that employees have the tools needed to perform their jobs safely

Monitor training of employees to ensure compliance

Facilitates and leads initiatives using new technologies, new policies, or new procedures to improve QC functions

May perform testing of high complexity methods

Serves as the primary link between production and QC teams

Other duties that support Operations, or Laboratory processes may be assigned

Off-shift support may be required to support the site 24/7 Operations

Qualification

QC Microbiology laboratory experienceLEAN manufacturing experienceLeadership skillsLIMS/Labware knowledgeSterile pharmaceutical microbiologyProject managementTeam developmentCommunication skillsProblem-solving skills

Required

Experience in production or quality control environment

Strong communication and leadership skills

Strong understanding of technical areas related to lab operations (including utilities, in-process testing, and finished product testing, along with associated equipment)

Ability to analyze and solve complex problems in a cross-functional team environment

Demonstrated ability to work with, manage and develop people in a complex, changing environment

Preferred

Bachelor's degree in a Science subject (Microbiology, or closely related subject)

QC Microbiology laboratory experience

Experience leading a team

Experience working in a LEAN manufacturing environment and working knowledge of lean leadership principals (including 5S, Value Stream Mapping, Identify and Eliminating Waste, GEMBA walks)

Working knowledge of LIMS/Labware, MODA, Veeva, Microsoft applications, SAP-PM and/or Maximo

Experience in sterile pharmaceutical microbiology lab testing including validation, technology transfer, change control

Demonstrated ability of successful Project management