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Catalent · 12 hours ago

Quality Assurance Inspector

Philadelphia, PA

Full-time

Onsite

Entry Level

1+ years exp

Catalent is a global leader in drug development and delivery, and they are seeking a Quality Assurance Inspector to join their Philadelphia facility. The role involves performing inspections and ensuring compliance with SOPs and cGMP, while collaborating with various teams to improve processes and maintain quality standards.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Ensure adherence to SOPs and cGMPs during incoming inspection, distribution, label control, returns, and destruction activities, supporting both Commercial and Clinical Operations

Verify and inspect incoming materials and collaborate with Quality and Project Management to resolve discrepancies

Inspect and release clinical and commercial drug products and components per customer specifications and Catalent SOPs, including review of labels and receipt documentation

Inspect and release shipping and distribution materials by verifying paperwork, picked items, and randomized containers for protocol compliance

Inspect and release materials designated for destruction by reviewing associated documentation and materials

Inspect and release clinical labels (open, randomized, booklet, multilingual) by comparing to approved proofs or label copy requests

Review BMS and chart recorder printouts for temperature, humidity, and pressure deviations, and inspect retain samples as needed

Maintain and report departmental metrics and support walkthrough audits of Supply Chain areas for GMP compliance

Review facility, label room, pest control, and sampling logbooks for compliance; update SOPs as needed and support deviation investigations and process improvements

Perform additional sampling or testing as requested, participate in customer audits, complete required documentation, and support other tasks assigned by QA Management

All other duties as assigned

Qualification

GMP experienceQuality inspectionSOP adherenceAnalytical thinkingMS Office proficiencyTeam collaborationEffective communicationAdaptability

Required

High school diploma or GED with a minimum of 2 years of quality or manufacturing experience within a GMP environment

Strong written and verbal communication skills

Effective interpersonal skills and ability to work collaboratively in a team environment

Proficient computer skills

Strong analytical thinking and sound judgment

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

Preferred

Bachelor's degree preferred with a minimum of 1 year of quality or manufacturing experience within a GMP environment

Experience with MS Office and inventory management systems is a plus

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

Tuition Reimbursement - Let us help you finish your degree or start a new degree!

WellHub- program to promote overall physical wellness

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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

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Trends of Total Sponsorships

2022 (1)