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Catalent · 1 week ago

Quality Specialist I

Lawrenceburg, IN

Full-time

Onsite

New Grad, Entry Level

Catalent is a global drug development and delivery leader, and they are seeking a Quality Assurance Specialist I to ensure adherence to quality standards in their production and packaging processes. The role involves conducting quality audits, documenting non-compliance, and ensuring compliance with FDA and cGMP standards.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Conduct thorough and detailed quality audits of lines to ensure products meet established quality standards

Audit paperwork of operators to ensure they are meeting quality standards

Report any deviations to QA Supervisor in complete appropriate details

Report any housekeeping issues that need attention

Document all areas of non-compliance and ensure corrective action to eliminate them

Work with Production and Packaging Managers, Supervisors, and hourly associates on daily issues and problems

Utilize computer to enter and track result data

Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards

Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training

Responsible for ensuring Dietary Supplement’s Identity, Purity, Strength and Quality

Participate in all necessary training is required to successfully perform job responsibilities

Other duties as assigned

Qualification

GMP knowledgeQuality systemsFDA complianceFood Safety Plan (HACCP)Food Quality Plan (FQP)Effective communicationAttention to detailTeam collaboration

Required

High School Diploma or GED required

For business and safety reasons, must be able to communicate effectively verbally and in written English

Ability to communicate with all line level positions and management

Knowledge of GMP and Quality systems

The employee must be able to lift and/or move up to 50 pounds

While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear

The employee is required to sit, climb, or balance and taste or smell

The position requires a great deal of walking and standing, approximately 85%

Conduct thorough and detailed quality audits of lines to ensure products meet established quality standards

Equipment verification including metal detector, x-ray, scales, etc

Audit paperwork of operators to ensure they are meeting quality standards

Report any deviations to QA Supervisor in complete appropriate details

Document all areas of non-compliance and ensure corrective action to eliminate them

Work with Production and Packaging Managers, Supervisors, and hourly associates on daily issues and problems

Utilize computer to enter and track result data

Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards

Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training

Responsible for ensuring Dietary Supplement's Identity, Purity, Strength and Quality

Participate in all necessary training is required to successfully perform job responsibilities

Preferred

BS in Food Science or related major is preferred

Benefits

152 hours of PTO + 8 paid holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (1)