Principal Representative, QA

We're hiring for a Principal Representative, QA in Bloomington, IN to support aseptic and sterility assurance programs.

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. 

A Principal Representative, QA's primary role is to support serve as a Subject Matter Expert and program implementor of the facility's aseptic program and policies. This role will support a team that is responsible for the development and implementation of all sterility assurance and microbiology strategies, policies, and procedures for the company's manufacturing facility. This is a full-time, salaried position and is 100% site based. The schedule is Monday – Friday, 2nd 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.

The Role

• Work with a cross-functional team to develop and implement sterility assurance and microbiology strategies, policies, and procedures.

• Assist leadership in the implementation of quality systems and compliance procedures, across the department.

• Service as a Subject Matter Experience in sterility assurance and aseptic operations.

• Participate in regulatory inspections and assist in leading the quality assessment of internal operations for any risks.

• Responsible for the Contamination Control Strategy to ensure and improve clean room controls within the facility, to minimize risk and cross-contamination.

• Other duties as assigned.

The Candidate

• Bachelor’s Degree with a minimum of 8 years relatable experience.

• Degree in microbiology or biology, highly preferred.

• Minimum of 12 years relatable experience, or demonstrated excellence in role, with justification.

• Minimum of 4 years GxP experience, or other regulated industry.

• Prior experience with sterility assurance and aseptic processing within a pharmaceutical or biotechnology manufacturing environment, highly preferred.

• Prior experience with regulatory inspections and audits, highly preferred.

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

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.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.