Associate Qa Representative Jobs

We're hiring for an Associate QA Representative 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 Associate QA Representative will be providing QA Floor Support for the Operations Department. This department has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping. This is a full-time, salaried position and is 100% site based. The schedule is Monday – Wednesday with rotating Thursdays, 6:00PM – 6:30AM.

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

• Assist with revision of GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMPs.
• Initiate deviations as required when observed on the floor.
• Partner with Manufacturing and other support teams.
• Accountable for execution of the QA on the Floor program.
• Performs on the floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.
• Other duties as assigned.
• Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product 70% of day is spent on the floor.
• Review batch documents.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.

The Candidate

• Must be able to read and understand English-written job instructions and safety requirements.
• Bachelor’s degree preferred.
• 0-2 years of quality assurance experience.
• 1 year GxP experience or other regulated industry.

Why you should join Catalent:

• 152 hours of paid time off annually + 8 paid holidays
• Defined career path and annual performance review and feedback process
• Community engagement and green initiatives
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Tuition Reimbursement
• Competitive salary with yearly bonus potential
• Medical, dental and vision benefits effective day one of employment
• Diverse, inclusive culture
• Generous 401K match and Paid Time Off accrual

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.