GMP QA Auditor: Analytical & Compliance Specialist

Catalent

Winchester (KY)

On-site

USD 65,000 - 90,000

Full time

25 hours ago

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Benefits offered by this job

Competitive PTO (8 holidays)

Medical, dental, vision benefits from

Job summary

Catalent’s Winchester, KY site seeks a QA Analytical Auditor to support release of QC lab materials and ensure GMP/analytical compliance. You will review data, participate in audits, support investigations, and help train Analysts in a fast-paced on-site environment.

Shift: Mon-Fri 8 AM–5 PM; 100% on-site in Winchester, KY. Requires a scientific degree and relevant lab experience with Empower software proficiency.

Qualifications

Bachelor’s degree in a scientific field 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.
Proficient in English verbal and written communication skills.
Ability to work effectively under pressure to meet deadlines.
Ability to multi-task with high efficiency.
Ability to coordinate and prioritize to support manufacturing and quality agreements.
Strong knowledge in Empower software.
Advanced knowledge and demonstrated performance in lab safety processes and ability to work safely with chemicals of varying potency.
General computer literacy including Microsoft Word and Excel.
Accurate testing on the first attempt under production pressure.
Proven ability to support multiple projects simultaneously while meeting deadlines and producing high-quality work with minimal supervision.
Proven track record of obtaining high-quality results with minimal errors and corrections.
Specific vision requirements include reading written documents and frequent use of computer monitor and chemical testing materials.

Responsibilities

Support release of raw materials, in-process, and finished products by reviewing GMP documents for compliance and technical accuracy.
Read and understand test methods from multiple compendia, internal Catalent methods, or customer/supplier methods.
Participate in customer and agency audits as necessary.
Assist in training Quality Control Analysts.
Assist in laboratory investigations.
Draft or review standard operating procedures as needed.
Draft or review corrective and preventive actions and audit responses as needed.
Perform other duties as required in support of Catalent Pharma Solutions high performance.