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Quva · 18 hours ago

Supervisor, Quality Assurance 2nd Shift

Bloomsbury, NJ

Full-time

Onsite

Mid Level

$75K/yr - $103K/yr

3+ years exp

Quva is a leading provider of health-system pharmacy services and solutions. The Supervisor, Quality Assurance is responsible for overseeing all QA aspects of compounding pharmaceuticals, ensuring compliance with legal and regulatory standards, and maintaining high-quality standards for pharmaceutical products.

Health CareManufacturingMedicalMedical DevicePharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Supervises Quality Assurance staff on assigned shift

Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions

Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions

Oversight of the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results

Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release

Periodically review records to verify that quality standards for each drug product is met

Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws

Responsible for maintaining QA records associated with internal and external testing

Responsible to maintain all testing equipment in compliance, calibration, and certification

Assists in developing policies and procedures related to QA

Promptly communicates with Operations regarding complaints, product issues/variance

Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation

Enforces applicable personnel policies and procedures

Qualification

Quality AssuranceCGMP complianceFDA regulationsSupervisory experienceEnvironmental monitoringDetail-orientedVerbal communicationWritten communicationInterpersonal skillsTeamwork

Required

A High School diploma or equivalent

Able to successfully complete a drug and background check

1 year of supervisory or management experience required

2 years' experience in Quality Assurance / cGMP / FDA regulated industry

Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation

Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas

Preferred

Bachelor's Degree in Life Science or other related field

Benefits

Comprehensive health and wellness benefits including medical, dental and vision

401k retirement program with company match

22 paid days off plus 8 paid holidays per year

Company

Quva

Quva is a national, industry-leading provider of health-system pharmacy services and solutions, including 503B sterile injectable outsourcing and data software solutions that generate insights to help power the business of pharmacy.

Founded in 2015

Sugar Land, Texas, USA

1001-5000 employees