Quality Control Auditor

Catalent Pharma Solutions • Winchester, KY

2d • Onsite

About The Position

Quality Control Auditor Position Summary Typical working hours for the position are Monday-Friday 8 AM-5 PM. This position is 100% on-site in Winchester, Kentucky. Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Quality Control Auditor supports release of all materials from the quality control lab. The Quality Control Auditor is responsible for GMP and technical review of raw materials/in process/finished goods data for release. The Role Support release of raw materials, in-process, finished product by reviewing GMP documents (data, notebooks, certificate of analysis, validation/qualification reports, etc) for compliance to internal SOPs and approved test methods as well as technical accuracy Read and understand test methods from multiple compendia (i.e. USP/NF, EP, JP), internal Catalent methods, or customer/supplier methods+ Participate in customer/agency audits as necessary Assist in training QC Analysts Perform analytical testing as needed Assist in laboratory investigations Draft or review standard operating procedures as needed Draft or review CAPAs and audit responses as needed Other duties as required in support of Catalent Pharma Solutions high performance

Requirements

• Bachelor’s degree in a scientific field (Chemistry or Biology preferred) with 3+ years in a Quality, Laboratory, Clinical, or Chemical Manufacturing Role (including internships or co-op experience).
• Ability to work well under pressure and maintain efficiency both on an individual and team basis.
• General computer literacy including use of Microsoft Word and Excel.
• Proven ability to support multiple project initiatives or multiple projects (either in-process, finished products or raw materials) simultaneously while meeting customer deadlines and producing high quality work and documentation with minimal training, supervision and direction.
• Proven track record of success of obtaining high quality results with minimal error problem reports and a minimal amount of write-up corrections
• Individual may be required to sit and stand for an extended period of time.
• Specific vision requirements include reading of written documents and frequent use of computer monitor and chemical testing materials.

Nice To Haves

• Previous analytical testing experience is preferred.
• Experience in the pharmaceutical industry preferred.

Responsibilities

• Support release of raw materials, in-process, finished product by reviewing GMP documents (data, notebooks, certificate of analysis, validation/qualification reports, etc) for compliance to internal SOPs and approved test methods as well as technical accuracy
• Read and understand test methods from multiple compendia (i.e. USP/NF, EP, JP), internal Catalent methods, or customer/supplier methods+
• Participate in customer/agency audits as necessary
• Assist in training QC Analysts
• Perform analytical testing as needed
• Assist in laboratory investigations
• Draft or review standard operating procedures as needed
• Draft or review CAPAs and audit responses as needed
• Other duties as required in support of Catalent Pharma Solutions high performance

Benefits

• Several Employee Resource Groups focusing on D&I
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• Generous 401K match
• 152 hours accrued PTO + 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. personal initiative. dynamic pace. meaningful work.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level