QC Scientist I

Work Schedule Weekend days

Environmental Conditions Laboratory Setting Job Description 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 Position Summary:

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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.