Job Description

Work Schedule

Weekend days

Environmental Conditions

Laboratory Setting

Job Title: Quality Control Scientist I

Reports To: Quality Control Supervisor

Group/Division: MBD

Career Band Band IV

Job Track: Quality Control

Position Location: Lenexa , Kansas

Number of Direct Reports none

Day/Shift (if applicable): M-T or Tu-F or F-M , could change based on business needs.

FLSA Status (Exempt/Non-Exempt): Exempt

Responsible for all quality control aspects of finished product testing. 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. Documentation control duties per Quality assurance compliance requirements.

Key Responsibilities:

• Review and maintain product compliance specifications, documentation control.
• Perform and interpret microbiology testing including growth promotion, biochemical, AST.
• Gain proficiency on all performance benches.
• Documentation of testing results and determining disposition.
• Maintain consistency in training in Master Control.
• Establish and maintain SOP criteria for inspection/testing.
• Responsible for maintaining department equipment and requesting consumables as needed.
• Exercise and monitor GMP and GDP compliance in work environment.
• Execute Stability Study testing in accordance with QA requirements.
• Work in conjunction with Customer Service Representatives to achieve on time product releases for standing orders and special products.
• Work with the continuous improvement program within the department.
• Work closely with a team in a fast paced laboratory setting.
• Understand and exercise all safety requirements and procedures.
• Assists in maintaining standards in accordance with GMP's/SOP's and ISO regulations.
• Willing to train the newly added team members.
• Participate in achieving department goals.

• Support all company policies.
• Performs other duties as assigned.

Minimum Requirements/Qualifications:

• Possess at least a 4 year degree in the biological sciences. Must have course work in microbiology with a laboratory or a 4 year degree
• A minimum combined 1-2 years of experience of in related QC/QA, microbiology laboratory work in a laboratory setting, or an equivalent combination of education and experience.
• Familiarity with FDA regulations for medical devices.
• Possess the ability to manage many tasks and in an organized fashion.
• Possess intermediate computer skills, preferably with experience in Microsoft word to include Word, Excel and PowerPoint programs. Experience working in SAP is a plus.
• 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 work weekend shifts and overtime when needed.
• Self-motivated, highly responsible and possess a good team work 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.
• Candidate must possess critical thinking skills.

This position has not been approved for Relocation Assistance.