Document Management Technician Jobs

Document Management Technician

This is a full-time, hourly position. The shift is Monday - Friday, 8:30am – 5:00pm.

The Quality Assurance department is responsible for all aspects of the quality assurance functions. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

This position requires a variety of skills necessary for biotech company operations. The position is to perform specific, defined task in support of the Quality Assurance department. Responsibilities can include providing clerical support to the Quality Assurance department (e.g., issuing records and other documents, posting documents for client review) and providing administrative support for Quality initiatives designed to enhance the Quality Management System and to ensure successful completion of key Quality projects.

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:

• Performs checkouts/check-ins or archived documents; Issuance/maintenance of controlled area SOP binders
• Other duties as assigned.
• Sharepoint maintenance; Trackwise support and set effective dates, CR reviews, DDAR’s in MES
• Generate periodic review CR for MES documents; author/Creator support
• Monitor suspended documents; generalized support of facility
• Supports on-call rotations, as needed; employee separation and perform department audits
• Files/maintains controlled documents; maintains stock of department supplies
• Logbook issuance and archival; worksheet issuance and archival.
• Frequent lifting and/or moving up to 25 pounds and occasional lifting and/or moving up to 50 pounds.
• Initial set issuance; performs scanning and filing.

The Candidate:

• Must be able to read and understand English-written job instructions and safety requirements.
• Technical Certificate or higher preferred
• 0-5 years of experience
• High School/GED
• GMP experience preferred

Why you should join Catalent:

• Tuition Reimbursement
• Community engagement and green initiatives
• 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
• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Medical, dental and vision benefits effective day one of employment
• Competitive salary with yearly bonus potential
• Generous 401K match and Paid Time Off accrual

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.