QA Representative, M-Th 10pm-8am Details

QA Representative, M-Th 10pm-8am

Catalent - Bloomington, IN

Employment Type : Full-Time

QUALITY ASSURANCE REPRESENTATIVE

A Quality Assurance (QA) representative’s primary duty is to support the quality function by overseeing GMP activities, documentation and reports. Responsibilities include participating in and supporting internal, client, regulatory and/or vendor audits to ensure internal and external operations that impact SISPQ are in compliance with regulations and procedures/policies, maintaining quality systems, processes, and facilities by observing manufacturing operations and reviewing documentation for compliance and executing assigned quality tasks (e.g., pre-approving instructions, reviewing documentation of executed instructions, reporting metrics, document drafting), providing review and approval of change request (e.g., Trackwise change controls and EDMS document change requests), approving item masters, product specifications and materials for usage in manufacturing, providing direction for and reviewing and approving deviations, corrective and preventive actions, vendor assessments, risk assessments, and nonconforming material reports, and reviewing resolution and effectiveness of corrective actions and audit responses.

The Role

• Requires knowledge and experience in own discipline; still acquiring higher-level knowledge and skills
• Builds knowledge of the company, processes and customers
• Solves a range of straightforward problems
• Analyses possible solutions using standard procedures
• Receives a moderate level of guidance and direction

The Candidate

• Bachelor’s degree preferred
• 2-5 years of experience with Bachelor’s degree
• 5+ years of experience or demonstrated excellence in role with justification
• 1 year GxP experience or other regulated industry
• Must be able to read and understand English-written job instructions and safety requirements.

Why you should join Catalent:

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross functional exposure to other areas
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 19 days of paid time off annually + 8 paid holidays

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.