Sr. Quality Assurance Specialist

Job Title: Sr. QA Specialist

Location: Cincinnati, OH (Hybrid)

Contract Length: 6-12 Months

Pay Rate: Commensurate with experience

Ready to make a real impact in pharmaceutical quality operations?

Kelly Scientific is looking for an experienced Sr. QA Specialist to resolve deviation investigations in a regulated pharma manufacturing environment. This is an exciting 6-month minimum (likely 1 year) contract opportunity with a leading pharmaceutical company, offering full benefits and the chance to apply your analytical skills to meaningful quality work.

What You’ll Do:

Lead detailed investigations into manufacturing deviations with a focus on non-critical issues.

Develop and execute investigation strategies with clear timelines and defined scopes.

Author comprehensive investigation reports, including issue definition, root cause analysis, and CAPA (Corrective and Preventive Action) recommendations.

Collaborate with cross-functional teams (Quality, Manufacturing, Engineering, etc.) to:

Establish communication and investigation strategies.

Define problem statements and identify root causes.

Recommend and document effective CAPAs and follow-up actions.

Leverage internal and external subject matter expertise to strengthen investigation quality.

Ensure timely documentation and escalation of findings as needed.

Manage multiple investigations simultaneously in a fast-paced, compliance-driven environment.

What You Bring:

Required:

Strong ability to quickly interpret technical data and perform structured investigations.

Clear, concise communication and exceptional technical writing skills.

Accountability and follow-through from start to finish of the investigation process.

Comfortable in a fast-paced, changing environment.

Proficiency with Microsoft Office; working knowledge of QMS platforms like Veeva is a plus.

Preferred:

Background in Pharmaceutical Manufacturing or other FDA-regulated industries.

Familiarity with cGMP guidelines and quality systems.

Experience using problem-solving methodologies (e.g., Fishbone, 5 Whys).

Bachelor’s degree in a Science, Engineering, or related technical field.

Previous experience in Quality Deviation or CAPA management.

Why You Should Apply:

Get your foot in the door with a top pharmaceutical organization.

Gain valuable experience leading quality investigations that ensure product safety and regulatory compliance.

Enjoy full benefits while working on a short-term contract with long-term impact.

Kelly Scientific is proud to be an Equal Opportunity Employer.