QA Associate

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Micron Technologies Dartford facility specializes in particle size reduction technologies and integrated analytical services for the pharmaceutical industry. It is equipped with advanced systems to handle highly potent and cytotoxic compounds in commercial volumes as well, and provide leading analytical services associated with particle size engineering and material characterization testing from early stage development to commercialization.

Catalent is currently recruiting for a QA Associate to join the Quality Assurance team. The QA associate will support operations with regulatory requirements.

Working hours:

Week 1; Monday – Friday 06.00 – 14.00

Week 2; Monday – Thursday 13.30 – 22.00 & Friday; 13.30 – 19.00

The Job:

• Responsible for the continuous support to operations activities in line with regulatory & Compliance.
• To be responsible for the individual batch record review and release by supervising the activity of pre-contract review (SOW) and the review of manufacturing and QC test data.
• To conduct investigations relative to complaint, liaise with the customer, participate in the CAPA implementation.
• To ensure that the services provided meet all regulatory requirements and client quality technical agreements.
• QA professional with extensive QA experience in batch review.
• Honesty and integrity, with a positive attitude to work.
• Thorough knowledge of EU, US, and other regulations relevant to Catalent pharmaceutical operations as well as a strong working knowledge of API manufacturing.
• Ability to work under pressure to meet tight and changing deadlines.
• Comfortable working collaboratively as part of a small team and able to influence others.
• Ability to organise and prioritise work and display an accurate and systematic approach to work.
• Ability to work unsupervised, be self-motivated and take the initiative to introduce new ideas and see those through to action. Have a Change Mindset.
• Must be customer oriented with good written and verbal communication skills.
• Must be able to make decisions in a timely manner.
• Must be a team player.
• Able to create and manage relationship cross-functionally.
• High level of proficiency in computer skills, including publishing tools, databases, word processing, project and spreadsheets.

The Candidate:

• Experience working within a GMP
• QA experience, including batch review.
• Good PC skills, including Microsoft packages.
• Understanding of QMS.
• Strong communication.
• Preferred: Graduate in Pharmaceutical Sciences or equivalent.
• Experience in a Quality Assurance GxP environment, with good working knowledge of the regulations and legislation relating to cGMP.
• Basic understanding of API manufacturing.
• Role requires technical understanding and problem-solving skills.
• Ability to work under pressure to meet tight and changing deadlines.
• Understanding of operational quality, EHS, and regulatory compliance.
• Work collaboratively as part of a small team and able to influence others.
• Competent PC skills including Microsoft.

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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

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.