This is a great opportunity for a quality professional with experience in supplier quality, QA systems, GMP manufacturing, audits, CAPA, deviations, change control, vendor management, or document control to support a regulated pharmaceutical manufacturing site. The role will support the site Supplier Quality Program and help ensure suppliers, vendors, materials, documentation, and related quality activities remain compliant with applicable regulatory requirements and internal procedures. The Quality Engineer, Supplier Quality will assist with supplier evaluations, supplier complaints, Quality Agreements, vendor change assessments, internal audits, corrective action follow-up, document management, and inspection readiness.
Quality Engineer, Supplier Quality — Pharmaceutical Manufacturing
Location: Noblesville, IN
Schedule: Monday–Friday, 7:30 AM–4:00 PM
Compensation: Up to $75,000 annually, depending on experience
Employment Type: Direct Hire / Permanent
Responsibilities
- Support the site Supplier Quality Program in compliance with applicable regulations, cGMP requirements, and internal procedures.
- Maintain operational compliance with applicable US and international regulatory agencies and guidelines, including FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, and cGMP requirements.
- Conduct supplier evaluations, including supplier questionnaires, risk-based assessments, and supplier audits as applicable.
- Issue supplier complaints and drive timely resolution, including supplier corrective action follow-up.
- Develop, review, and maintain Supplier Quality Agreements.
- Perform initial assessments of vendor changes, route changes for functional review, and track actions through completion.
- Generate or review Change Controls related to SOPs, Standard Test Methods, Data Sheets, and other controlled documentation.
- Support or serve as lead investigator for exceptions, deviations, supplier quality issues, and other quality events.
- Apply quality tools such as FMEA, Fishbone, 5 Why, Risk Analysis, and root cause analysis tools to support investigations and continuous improvement initiatives.
- Participate in internal audits and assess corrective action recommendations.
- Support FDA and other regulatory inspections, customer audits, and site audit-readiness activities.
- Perform statistical analysis of quality or laboratory data in support of investigations, cost savings, and continuous improvement initiatives.
- Execute assigned project tasks in accordance with established timelines.
- Perform filing, scanning, and document management activities as needed.
- Maintain current knowledge of applicable regulations related to microbiology, chemistry, cGMPs, and pharmaceutical quality systems.
- Ensure a safe and quality-focused work environment through training, awareness, and compliance with site procedures and regulatory guidelines.
Qualifications
- Bachelor of Science degree in Life Sciences, Engineering, or a related technical discipline required; equivalent experience may be considered.
- 3+ years of quality experience in a pharmaceutical, biotechnology, medical device, or other FDA/ISO-regulated manufacturing environment.
- Experience with supplier quality, supplier evaluations, supplier complaints, supplier corrective actions, vendor changes, supplier audits, or Quality Agreements strongly preferred.
- Strong understanding of regulated quality systems and cGMP requirements.
- Working knowledge of cGMP guidelines and their application in a controlled aseptic manufacturing environment preferred.
- Experience with quality systems such as Change Control, CAPA, Deviations, Complaint Investigations, Internal Auditing, and Document Management.
- Experience using statistical tools, data analysis, trending, or quality metrics in support of investigations or continuous improvement.
- Proficiency with Microsoft Office applications, including Excel.
Preferred Experience
- Pharmaceutical manufacturing, sterile manufacturing, aseptic manufacturing, radiopharmaceutical, biotechnology, or medical device manufacturing experience.
- Supplier qualification, supplier performance monitoring, vendor change assessment, or supplier audit experience.
- Experience supporting FDA inspections, customer audits, internal audits, or regulatory inspection readiness.
- Experience using root cause analysis tools such as 5 Why, Fishbone, FMEA, Pareto analysis, or risk assessment tools.
- Experience with controlled documents, SOPs, quality records, and electronic quality systems.
Skills and Competencies
- Strong problem-solving, decision-making, verbal communication, and written communication skills.
- Ability to prioritize work based on business needs in a fast-paced regulated manufacturing environment.
- Ability to exercise independent judgment in planning, organizing, and completing assigned tasks.
- Strong documentation skills and attention to detail.
- Ability to work cross-functionally with Quality, Manufacturing, Supply Chain, Technical Operations, and external suppliers.
- Results-oriented with the ability to drive issues to compliant closure.
- Ability to communicate with and positively influence internal teams and external supplier contacts.
Working Conditions
- Must be willing to work in a plant that produces radioactive materials and participate in safety programs designed to minimize potential exposure.
- Must be willing to wear required PPE and hearing protection as needed.
- Role may involve sitting, standing, walking, bending, kneeling, crouching, pushing, pulling, reaching, and physically negotiating stairs and evacuation ladders with or without accommodation.
- May require lifting up to 70 pounds with proper safety practices and use of material handling devices when available.
- Work may include exposure to manufacturing areas, mechanical or moving parts, and materials requiring appropriate safety controls.
- Must be willing to complete required safety training within allotted timeframes.
- May occasionally require work outside of regular hours, including off-shift, weekend, or holiday support based on business needs.
#IND-SPG
Estimated Min Rate: $55,000 / yr
Estimated Max Rate: $75,000 / yr
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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