Quality Assurance Engineer

Yoh is hiring a Quality Assurance Engineer for our pharmaceutical manufacturing client in Noblesville, Indiana. This role is ideal for a hands-on quality professional with experience supporting cGMP manufacturing operations, deviation investigations, CAPAs, change controls, quality documentation, and regulatory audit readiness. The Quality Assurance Engineer will help maintain compliance with U.S. and international regulatory requirements while supporting quality systems, manufacturing investigations, continuous improvement initiatives, and documentation review within a regulated pharmaceutical environment.

Quality Assurance Engineer
Location: Noblesville, Indiana
Schedule: Onsite
Salary: Target salary up to $80,000 annually, depending on experience

Responsibilities:

• Maintain operational compliance with applicable U.S. and international regulatory agencies and guidelines, including FDA, DEA, EU, Health Canada, TGA, PIC/S, ISO, USP, NRC, and cGMP requirements.
• Identify, investigate, and support resolution of deviations, exceptions, and quality events.
• Implement and support corrective and preventive actions.
• Generate, review, and/or approve change controls related to batch records, standard operating procedures, standard test methods, specifications, data sheets, and other GMP documentation.
• Use quality tools such as FMEA, Fishbone diagrams, 5 Why analysis, risk assessments, and other root cause/problem-solving methods to support investigations and special projects.
• Analyze data in support of investigations, cost savings initiatives, continuous improvement projects, and quality system improvements.
• Author and/or perform peer review of annual product quality reviews.
• Support regulatory agency inspections and on-site audits as needed.
• Maintain current knowledge of applicable U.S. and international quality regulations.
• Ensure a safe and quality-focused working environment through training, awareness, and compliance with safety, quality, and SOP requirements.
• Support work in a pharmaceutical manufacturing environment where radioactive materials may be present, following all required safety and quality procedures.

Qualifications:

• Bachelor of Science degree in Biology, Chemistry, or a related scientific discipline preferred; relevant work experience may be considered in lieu of degree.
• 3+ years of relevant quality assurance, quality systems, or GMP pharmaceutical manufacturing experience.
• Experience with deviation investigations, CAPAs, change controls, root cause analysis, and GMP documentation review.
• Knowledge of cGMP, FDA regulations, and regulated manufacturing quality systems.
• Ability to resolve problems, handle conflict, and make effective decisions under pressure.
• Strong attention to detail and ability to analyze data to support quality decisions.
• Ability to perform simple to complex math calculations and accurately input and analyze data using computer systems.
• Strong written and verbal communication skills.
• Ability to work onsite in Noblesville, Indiana.

Preferred Experience:

• Pharmaceutical, sterile injectable, aseptic manufacturing, radiopharmaceutical, biotech, or CDMO experience.
• Experience supporting FDA or other regulatory agency inspections.
• Experience with annual product quality reviews.
• Familiarity with FDA, DEA, NRC, USP, EU GMP, Health Canada, TGA, or PIC/S requirements.

#IND-SPG

Estimated Min Rate: $65000.00
Estimated Max Rate: $80000.00


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.

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