Job Description

Work Schedule

Weekend days

Environmental Conditions

Laboratory Setting

Job Title: Quality Control weekend Team Lead

Reports To: Quality Control Supervisor

Group/Division: SDG/MBD

Career Band: Band 5

Position Location: Lenexa Kansas

Number of Direct Reports 3, potential for more

Day/Shift (if applicable): Friday to Monday, could possible change based on business needs.

FLSA Status (Exempt/Non-Exempt): Exempt

Oversee the weekend operation of the Quality Control Laboratory. Ensure that performance of finished product is in compliance with testing standards per IFU and SOP's in addition to customer requirements and regulating agencies' guidelines.

Key Responsibilities:

• Assist Quality Control Supervisor in daily laboratory operations and assign job duties to Quality Control staff as needed.
• Manage weekend team to include performance management and goal setting.
• Provide lab bench coverage during absences.
• Oversee personnel issues within the department.
• Develop and train new employees, maintaining consistency in training/development of existing personnel.
• Create, update and maintain SOP’s for lab procedures in Master control in accordance with FDA and ISO regulations as assigned.
• Initiate Issue Review’s and implement root cause counter measures as directed.
• Initiate IN’s for the Out of specifications products to submit to QA.
• Work closely with other Quality departments to provide up to date product information.
• Exercise and monitor GMP and GLP compliance in work environment.
• Lead and facilitate continuous improvement program within department.
• Understand and exercise all safety requirements and procedures.
• Work closely with a team in a fast-paced laboratory setting.
• Responsible for achieving department goals.
• Maintain consistent training in Master Control.
• Understand and exercise all safety requirements and procedures.
• Support all company policies.
• Performs other duties as assigned.

Minimum Requirements/Qualifications:

• Possess a 4-year degree in the biological sciences – microbiology preferred
• Preferred 1-3 years in a lab lead/supervisory roll with direct reports
• 4 years microbiology lab experience preferred
• Familiarity with plate and tube media, bacterial and fungal culturing
• Familiarity with FDA regulations for medical devices.
• Understanding of USP and CLSI requirements.
• Possess the ability to manage many tasks and in an organized fashion.
• Possess computer skills - experience in Microsoft Office to include Word, Excel and PowerPoint programs. Experience working in SAP
• Listen to, and follow, written and verbal instructions.
• Able to adapt and to learn new procedures and to maintain a scientific and objective approach.
• Must be available to adjust work shift when needed.
• Self-motivated, highly responsible and possess a good positive teamwork spirit.
• Excellent verbal and written skills in English.

Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)

• Candidate must be a good time manager.
• Candidate must be willing to put in overtime when needed to complete tasks.
• Candidate must be a good team player/participant on teams.
• Candidate must have a high sense of responsibility and Positive attitude.
• Candidate must possess critical thinking skills.

This position has not been approved for Relocation Assistance.