Sobre esta vaga de Compliance Specialist II na Catalent
About Site
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
Position Summary
We have an opportunity for a Compliance Specialist II to join our team. In this role, you will support cGMP business units to ensure a high level of compliance. You will work under the guidance of a supervisor to ensure all documentation meets regulatory requirements, good manufacturing practices, and standard operating procedures. This position is key to maintaining quality and readiness for client interactions.
Shift: Mon to Fri 8am-5pm
Location: Kansas City, MO
100% Onsite
The Role
Review executed batch records and documentation to ensure conformance to cGMPs, SOPs, and other protocols.
Draft and review batch records for use by pharmaceutics and operations personnel.
Recommend batch record changes for continuous improvement per approved SOPs and collaborate with cGMP business units to resolve inconsistencies.
Draft standard operating procedures for processes used by pharmaceutics and operations personnel.
Complete all assigned training and follow training guidelines strictly.
Maintain high-quality manufacturing documentation in accordance with regulatory guidance and site SOPs.
Maintain readiness for on-site clients.
Perform spot-checks of experimental areas and assets, and track laboratory notebooks.
Track and trend batch record initiation, approvals, updates, and feedback after execution.
Perform all other duties as assigned.
The Candidate
Minimum Requirements
High School Diploma or General Educational Development (GED) or equivalent years of experience in a regulated industry.
Ability to work effectively under pressure and meet deadlines while maintaining attention to detail.
Ability to multitask and follow a variety of instructions furnished in written, oral, diagram, or schedule form.
Mathematical and scientific reasoning ability.
Strong computer skills and proficiency in Microsoft Word and Microsoft Excel.
Proactive in addressing work issues at the individual level.
Preferred Skills & Background
Not applicable.
Why You Should Join Catalent
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture.
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Competitive paid time off plus 8 paid holidays.
Community engagement and green initiatives.
Medical, dental, and vision benefits effective day one of employment.
Tuition reimbursement.
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, 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.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
