The QA Specialist – Raw Materials (Weekend AM) is responsible for providing Quality oversight of QA raw materials across Catalent Maryland sites on Friday, Saturday and Sunday to ensure compliance with applicable regulations, guidance’s, industry standards and Catalent policies/procedures to support GMP manufacturing.

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?

Shift: 3x 12hrs – Friday, Saturday, Sunday (6am-6pm)

The Role:

• Conducts critical reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records, item request form) by exercising judgement within defined procedures and regulations.

• Works with Materials Control to quarantine and disposition all GMP materials in a timely manner across all Catalent Maryland sites

• Review and revise Standard Operating Procedures as it pertains to the disposition of Raw Materials

• Review and approve Material Specifications

• Provide support in Deviations, Change Controls and CAPAs as it pertains to the disposition of raw materials.

• Support internal audits of GMP systems and facilities

• Works cross-functionally with Materials Control, Purchasing, Manufacturing, Quality Control and other departments to resolve raw material quality issues and provide assistance when needed

• Continually evaluates Quality and Materials Control processes and procedures to improve efficiency and ensure compliance to appropriate GMPs

• Collaborate with other members of Quality Assurance, including cross training where necessary, for performing duties and tasks in support of Catalent’s Quality Systems

The Candidate:

• Bachelor’s degree in a Science or Engineering field preferred with 2 years of experience or an Associates Degree with 5 years of experience in an FDA regulated industry.

• Hands-on work in a Quality Assurance field with a strong familiarity of general GMP documentation and materials management.

• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

• Have strong attention to detail.

• Ability to manage multiple priorities and tasks in a dynamic environment.

• Good written, verbal and interpersonal skills to effectively interact with cross-functional teams.

• Ability to exercise Quality decisions to determine appropriate corrective actions

• Ability to work in a team environment

• Knowledge of Pharmaceutical CGMP Regulations

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.