QA Inspector (Production) - 2nd Shift jobs in United States
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Catalent · 20 hours ago

QA Inspector (Production) - 2nd Shift

Catalent is a global leader in drug development and delivery, known for its innovative approach and commitment to quality. They are seeking a Quality Assurance Inspector to monitor and audit packaging operations, ensuring compliance with cGMP standards and improving operational efficiencies. The role involves real-time documentation review, collaboration with cross-functional teams, and supporting quality initiatives in a fast-paced environment.

BiotechnologyHealth CareManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Ensure SOPs and cGMP requirements are consistently followed during packaging operations, including real-time auditing and monitoring
Verify and reconcile materials before/after production and collaborate with Production, Materials Management, and Project Management to resolve discrepancies
Inspect and release packaging rooms, confirming proper cleaning and material clearance per GMP expectations
Document activities in applicable logbooks and review production logbooks and batch records for GMP and documentation accuracy
Support mechanics with Operational Verifications (OVs), equipment setup, and related records prior to and during packaging runs
Review Production and QA Protocols before job start and perform/document hourly QA inspections per SOP and protocol requirements
Monitor adherence to GMP standards during packaging and ensure batch documentation aligns with inventory system entries and printed labels
Review environmental monitoring outputs (temperature, humidity, pressure) and ensure clean storage rooms meet approval criteria
Conduct floor, warehouse, and clean storage walkthroughs to verify GMP compliance; document shift activities in QA turnover logs
Partner with cross‑functional teams on deviations, investigations, and troubleshooting; support sampling/testing requests, equipment parts review, and customer audits
Performs other duties or tasks as requested or required by QA Management

Qualification

GMP complianceQuality assurance auditingDocumentation accuracyAnalytical thinkingMS Office proficiencyTeam collaborationEffective communicationProblem-solving

Required

High school diploma or GED with a minimum of 2 years of quality or manufacturing experience within a GMP environment; Bachelor's degree preferred with a minimum of 1 year of quality or manufacturing experience within a GMP environment
Strong written and verbal communication skills
Proven track record of monitoring/auditing for quality assurance and/or identifying potential efficiencies in a production environment preferred
Effective interpersonal skills and ability to work collaboratively in a team environment
Proficient computer skills; experience with MS Office and inventory management systems is a plus
Strong analytical thinking and sound judgment and has the ability to thrive in a dynamic environment with shifting priorities
Comfortable being on your feet and moving between multiple warehouse areas
Ability to quickly learn and apply QA auditing techniques
Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-25 pounds
Willingness to work overtime, frequently in cold environments, and track, monitor and maintain production rates, labor hours and downtime

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits
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WellHub- program to promote overall physical wellness
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Company

Catalent

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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.

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)

Funding

Current Stage
Late Stage
Total Funding
unknown
2021-01-06Acquired

Leadership Team

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Alessandro Maselli
President & Chief Executive Officer
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Charles Lickfold
Senior Vice President, Chief Information Officer
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Company data provided by crunchbase