What are the responsibilities and job description for the QA Technician- Document Control position at Catalent?
The QA Technician - Document Control oversees the revision, issuance and tracking of controlled documents used to support the Phase I/II/III and commercial GMP manufacture of bulk and sterile fill biologics. Mature professional capable of working independently and in a team setting. Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to effectively prioritize based on criticality.
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent?
The Role:
- Will work directly with Clients, the QA department and other Paragon departments to revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.
- Ensures basic grammatical accuracy and completeness when revising documents.
- Filing, tracking and archival of GMP documentation.
- Conducts internal audits of Paragon systems and documents where needed to ensure compliance to applicable Paragon Policies and SOPs.
- Provides reports to Upper Management and Project Management regarding document status
- Maintains databases used for tracking various GMP documentation.
- Support regulatory (FDA, EMA) and client audits/inspections of Paragon.
- Works under general supervision to meet project goals.
- Compile and provide applicable metrics for periodic Management review.
- Support Process Development (PD) as needed.
- Will work closely with various departments at Catalent to resolve quality issues and offer assistance as needed.
- Processes, distributes, and maintains controlled documentation (i.e., SOPs, SMPs, material specification, logbooks, etc.) using a document control system.
- Issuance of Batch Production Records.
- Decisions or recommendations consistently result in favorable project results and client satisfaction.
- Other duties as assigned
The Candidate:
- High School Diploma and 1-2 years experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries in a Document Control position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc.
- Microsoft Word and Microsoft Access experience
- Exposure to 21 CFR Parts 210 & 211, biotechnology, Process Development (PD) and electronic validated computer systems a plus.
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.
