What are the responsibilities and job description for the Quality Systems Engineer position at YOH Services LLC?
Quality Systems Engineer
Category: Life Science
Employment Type: Direct Hire
Reference: BH-391515
Yoh is hiring for a Quality Systems Engineer
for our Pharmaceutical Manufacturing
client in Noblesville, Indiana.
What you will be doing:
- Identify and implement Corrective Actions Investigate Exceptions (Deviations).
- Generate or review Change Controls for Batch Records, Standard Operating Procedures, Standard Test Methods, Specifications, 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 analysis of data in support of investigations, cost savings, continuous improvement initiatives Work with radioactive materials.
- Ensure a safe and quality working environment through training, awareness, and compliance with safety/Quality guidelines and SOPs.
- Maintain current knowledge of US and international quality regulations.
- Author or perform peer review of annual product quality reviews.
- Provide support for regulatory agencies (i.e., FDA, HC, TGA, EU, etc.) on-site audits, as required.
- 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.).
- Bachelor of Science in Biology, Chemistry or related field required.
- Work experience may be considered in lieu of degree.
- 3 or more years of experience with CAPA, Deviations and audits
- Previous experience in a GMP environment
- 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.
Estimated Min Rate: $35.00
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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.