Associate, Quality Assurance

We have an opportunity for an Associate, Quality Assurance to join our team. This role involves performing varied work that requires some evaluation and originality while following established protocols and work plans. The position supports quality oversight of manufacturing processes and ensures compliance with cGMPs, FDA, and MHRA guidelines. The successful candidate will contribute to maintaining high standards of product quality and safety while supporting continuous improvement initiatives., * Oversee Quality support functions associated with the manufacturing of products.

• Review batch records, cleaning records, and logbooks.
• Ensure products are manufactured according to applicable current Good Manufacturing Practices (cGMPs), FDA guidelines, MHRA guidelines, regulations, and internal Standard Operating Procedures (SOPs).
• Identify deviations during manufacturing and provide direction on appropriate corrective actions.
• Review and approve batch documentation for adherence to SOPs and cGMPs.
• Participate in Quality Assurance programs, procedures, and controls to ensure products meet established standards and agency guidelines.
• Complete monthly and daily facility audits.
• Assist with manufacturing floor activities, including equipment and room approval and facility compliance.
• Perform other duties as assigned., 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.

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• Bachelor’s degree in a scientific discipline or at least one year of Manufacturing or Quality Assurance experience in a Good Manufacturing Practice (GMP) environment.
• Ability to follow instructions, guidance, and direction from others.
• Use existing procedures to solve routine problems.
• Apply all elements of the quality system to identify, classify, and control the status of finished products.
• Proactive in addressing work issues individually and within a team.
• Ability to follow written, oral, diagram, or schedule instructions.
• Strong mathematical and scientific reasoning skills.
• Ability to identify abnormal data and potential quality or compliance concerns and escalate to management.
• Excellent written and verbal communication skills with internal and external stakeholders.
• Lead by example in alignment with Catalent’s values and culture.
• Recognize unmet needs within the department and business.
• Collaborate effectively with peers and demonstrate leadership capabilities in a matrix environment.
• Strong time management and efficiency skills.
• Well organized with the ability to multitask.
• Work effectively under pressure to meet deadlines.
• Proficient in computer technology, including hardware and software used for common tasks (Word, Excel, Outlook, PowerPoint basics).

• 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’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses., 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.