Senior Representative, QA

We're hiring for a Senior Representative, QA to support our quality systems auditing team in Bloomington, Indiana! 

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

The Senior Representative, QA will be responsible for all facility audits and providing support to the quality systems team. This is a full-time, salaried position and is 100% site based. The schedule is Monday – Friday 1st shift. 

Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Supports customer audits, including co-hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response follow up actions.

• Participates in internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures, and communicating audit findings to key stakeholders.

• Complete Back Room Audit Responsibilities during external audits; managing and completing requests, contacting and orchestrating Subject Matter Experts, Preparing documents into presentable format for auditors.

• Complete Front Room Audit Responsibilities during client audits; facilitate the audit in lead or support role, manage positive client relations, actively host client interactions.

• Review and approve responses to audit findings.

• Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes.

• Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations.

• Other duties as assigned. 

The Candidate

• Bachelor’s Degree in a STEM discipline, highly preferred.

• Minimum of 5 years relevant experience with a bachelor’s degree, required.

• Minimum of 8 years relevant experience or demonstrated excellence in role, with justification.

• Minimum of 2 years GxP experience, or other regulated industry.

• Prior experience in cGMP auditing, both internal and external, highly preferred.

• Robust interpersonal skills, organizational skills, and project management skills, with the ability to balance multiple priorities and projects.

• Must be able to read and understand English-written job instructions and safety requirements.

• A strong working knowledge of quality systems and processes, preferred.

Why you should join Catalent:

• Medical, dental, vision, and wellness benefits are effective on the first day of employment.

• Potential for career growth on an expanding team and organization.

• 152 hours of paid time off annually plus 8 paid holidays.

• Community engagement and green initiatives.

• Engaging D&I Employee Resource Groups.

• Tuition reimbursement program.

• Generous 401K match.

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