JOB SUMMARY

The Quality Assurance Document Control is responsible in preparing customer files, review and approve batch records, and release batch records and finished product. The Quality Assurance Document Control individual acts as the primary liaison to our customer’s quality assurance groups for batch record review and release. The Quality Assurance Document Control manages the communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.

THE HOURS FOR THIS POSITION ARE MONDAY-FRIDAY, 12PM-8:30PM

THE ROLE

• Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.

• Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.

• Monitor schedule for production priorities.

• Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures.

• Confirm proper randomization schedule utilization for correct patient treatment group assignment.

• Primary liaison with client for batch release.

• Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.

• Ensure timely release of batch for protocol initiation date.

• Release batch within scheduling database.

• Release batch within JDE inventory management system.

• Record and track errors and not-right-first-time to maintain departmental metrics.

• Archive batch documents onto shared drive and within archive room.

• Communicates SQDC countermeasures and safety issues to Quality Management.

• Ensures QADC metrics are met or acts to correct..

THE CANDIDATE

• BA/BS Degree OR Minimum of a High School Diploma with relevant industry experience.

• Prior GMP experience strongly preferred.

• Experience with inspections or Batch Record Review a plus.

• Good organizational/time management skills and ability to multi-task.

• Challenges status quo and initiates improvements.

• Communication skills.

• Good math skills.

• Advanced computer skills - including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDE

POSITION BENEFITS

• Lots of Growth/Development opportunities

• 19 Days of PTO (Paid Time Off) per year

• Tuition Reimbursement Program

• Defined career path and annual performance review & feedback process

• Cross-functional exposure to other areas within Catalent

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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.