Specialist I, Form/Fill

Specialist I, Form/Fill

This is a full-time, hourly position. The shift is Tuesday - Friday, 4:30pm - 3:00am.

The Drug Product Support department is responsible for supporting the Operations Team in the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. This includes Primary and Secondary Operations. Manufacturing cGMP production support activities include audit preparation, audit performance, documentation and metric tracking, documentation review, deviation identification and authoring, Corrective Actions, Change Management, and process improvements. The department is comprised of three distinct, but integrated, channels. The Manufacturing Auditing team oversees internal and external audits. The Analyst Team reviews batch production records, forms and logs. The third team is Process Specialists and Investigators that investigate and author deviations, implement corrective actions and process improvements.

This position's primary duty is to support an assigned production area regarding review of documents, including logs, forms and batch records. This would also include data collection and metric reporting.

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:

• Has developed knowledge and skills through formal training or considerable work experience; Operates within established procedures with a moderate level of guidance and direction
• Proficient in Excel/Word/Teams and other data entry software; Acquires advanced skills to perform routine tasks; Performs review of master batch records
• Demonstrates the competency to resolve corrections with collaboration from a wide range of roles across several shifts and departments
• Initiates deviations in Global Trackwise in collaboration with other departments; Supports MS&T and QA to improve processes
• Performs metrics and data collection in Minitab, Discoverant, JDE, and Sharepoint; Supports manufacturing documentation through real time observations in Sharepoint
• Ability to read, comprehend, and enforce standard operating procedures, work instructions, and master batch records
• Operates within clearly defined standard operating procedures and adheres to quality guidelines; Works on projects to support the team by actively participating and suggesting solutions to problems
• Acts as an informal resource for colleagues with less experience; Spend time on production floor reviewing documents real time
• Other duties as assigned

The Candidate:

• High School Diploma/GED required with 1-2 years relevant experience OR
• Associate degree with 1+ years experience OR
• Bachelor's degree
• Manufacturing experience preferred
• GMP experience or regulated industry 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

About Catalent:

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position.

Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

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.