CAREER PORTAL

Sr. Quality Control Testing Engineer

Yoh is hiring for a QC Test Engineer for our Pharmaceutical client in Noblesville, Indiana. This is a great opportunity to put your skills to the test and join a growing team.

Summary of Position The Quality Control Testing Engineer role is responsible for supporting the Quality Control organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.


 Functions

• Support or serve as lead investigator for Out of Specifications results, identify and implement Corrective Actions.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
• Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc.
• Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.
• Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives.
• Generate, execute, and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s.
• Maintain current knowledge of federal and international regulations regarding Microbiology, Chemistry and cGMP's.
• Provide support for FDA or other regulatory agencies for on-site audits.

Requirements/Education

• Bachelor of Science in Biology, Chemistry or related field required.
• 5 or more years of relevant experience required. 
• Experience investigating exceptions and out of specifications preferred.
• Must be able to resolve problems, handle conflict and make effective decisions under pressure, and conduct Root Cause Analysis.
• Ability to do simple to complex math calculations, input data into the computer and analyze data as required.
• Must be proficient in use of Microsoft suite office products.
• Good computer skills, including utilizing personal computers and data entry programs Good hands on, analytical, and problem solving and decision making skills.
• Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment.

Estimated Min Rate: $25.90
Estimated Max Rate: $37.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.