Representative, QA

We're hiring for a Representative, QA to support batch record review 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 Representative, QA will be responsible for reviewing and dispositioning batch records. This position is a part of the Quality Assurance Operations group, which 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 - 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

• Accountable for review and approval of project related documents for Master Batch Production Records.
• Responsible for occasional interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships.
• Supports issuance of controlled documents for production, including Batch Production Records, Product Labels, and forms.
• Assist with revision of GMP documentation such as Standard Operating Procedures and forms, as needed.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Other duties as assigned.

The Candidate

• STEM bachelor's degree, preferred
• 2 - 5 years of experience in pharmaceutical manufacturing, or related, environment with bachelor's degree, required
• 5 years of experience in pharmaceutical manufacturing, or related, or demonstrated excellence in role with justification, required.
• 1-year GxP experience or other regulated industry, required.
• Prior cGMP experience preferred.
• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
• Strong analytical and problem-solving abilities. Capable of making decisions using experience along with site process and procedures.
• 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:

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

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.