Catalent
Join to apply for the
QC Auditor
role at
Catalent
in Winchester, Kentucky. This position is 100% on‑site.
Monday‑Friday 8 AM – 5 PM. 2+ years of related experience required.
The Role
Support release of raw materials, in‑process, finished product by reviewing GMP documents (data, notebooks, certificates of analysis, validation/qualification reports, etc.) for compliance with internal SOPs and approved test methods as well as technical accuracy.
Read and understand test methods from multiple compendia (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.
The Candidate
Bachelor’s degree in a scientific field (Chemistry or Biology preferred) with 2+ years of related experience required. Alternate degrees in a non‑scientific field may be accepted with at least 3 years of relevant experience in a material testing laboratory.
Ability to work well under pressure and maintain efficiency both individually and on a team.
General computer literacy including use of Microsoft Word and Excel.
Previous analytical testing experience is preferred. Experience in the pharmaceutical industry preferred.
Proven ability to support multiple project initiatives simultaneously while meeting customer deadlines and producing high‑quality work and documentation with minimal supervision.
Individual may be required to sit and stand for an extended period of time. Specific vision requirements include reading written documents and frequent use of a computer monitor and chemical testing materials.
Why You Should Join Catalent
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.
Seniority level
Entry level
Employment type
Full-time
Job function
Finance and Sales
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Catalent by 2x.
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, please contact DisabilityAccommodations@catalent.com with your request.
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QC Auditor
role at
Catalent
in Winchester, Kentucky. This position is 100% on‑site.
Monday‑Friday 8 AM – 5 PM. 2+ years of related experience required.
The Role
Support release of raw materials, in‑process, finished product by reviewing GMP documents (data, notebooks, certificates of analysis, validation/qualification reports, etc.) for compliance with internal SOPs and approved test methods as well as technical accuracy.
Read and understand test methods from multiple compendia (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.
The Candidate
Bachelor’s degree in a scientific field (Chemistry or Biology preferred) with 2+ years of related experience required. Alternate degrees in a non‑scientific field may be accepted with at least 3 years of relevant experience in a material testing laboratory.
Ability to work well under pressure and maintain efficiency both individually and on a team.
General computer literacy including use of Microsoft Word and Excel.
Previous analytical testing experience is preferred. Experience in the pharmaceutical industry preferred.
Proven ability to support multiple project initiatives simultaneously while meeting customer deadlines and producing high‑quality work and documentation with minimal supervision.
Individual may be required to sit and stand for an extended period of time. Specific vision requirements include reading written documents and frequent use of a computer monitor and chemical testing materials.
Why You Should Join Catalent
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.
Seniority level
Entry level
Employment type
Full-time
Job function
Finance and Sales
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Catalent by 2x.
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, please contact DisabilityAccommodations@catalent.com with your request.
#J-18808-Ljbffr