QA Monitor – 2nd Shift jobs in United States
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KVK Tech, Inc. · 1 month ago

QA Monitor – 2nd Shift

KVK Tech, Inc. is seeking a detail-oriented QA Monitor to join their team in Newtown, PA. The QA Monitor is responsible for ensuring that all cleaning, sanitation, and line clearance activities comply with cGMP, internal SOPs, and FDA expectations, providing continuous oversight and collaboration with various teams.

ManufacturingMedical DevicePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Perform independent visual verification of room, equipment, and utensil cleaning prior to use and document results on approved QA monitoring forms
Verify that cleaning logs, line clearance forms, and housekeeping records are completed accurately, legibly, and in accordance with cGMP and SOP requirements
Conduct routine on-floor monitoring of cleaning and sanitation practices to ensure proper methods, detergent usage, and equipment labeling are followed
Inspect and confirm compliance with 'Cleaned' and 'To Be Cleaned' status tags across manufacturing and packaging areas
Observe line clearance activities to ensure complete removal of prior product, components, and documents before batch startup
Report, document, and escalate any nonconformance, residue, or GMP deviation identified during monitoring

Qualification

CGMP knowledgeQA monitoringCleaning documentationAttention to detailObservational skills

Required

High School Diploma or equivalent
Working knowledge of cGMP cleaning and line clearance requirements
Ability to interpret, complete, and review QA and cleaning documentation with accuracy and attention to detail
Strong observational skills with the ability to identify residue, labeling discrepancies, or noncompliant cleaning practices

Preferred

Associate degree in Life Sciences or a related technical field
0–2 years of experience in a cGMP pharmaceutical or manufacturing environment
Experience with cleaning, sanitation, or QA monitoring

Benefits

401(k) with company match
Health, vision, and dental Insurance
Childcare expense reimbursement
Tuition reimbursement
Annual bonus eligibility
Annual merit increases
Paid Time Off and Flexible Holidays

Company

KVK Tech, Inc.

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KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs.

H1B Sponsorship

KVK Tech, Inc. 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
2025 (8)
2024 (18)
2023 (15)
2022 (27)
2021 (27)
2020 (28)

Funding

Current Stage
Late Stage

Leadership Team

A
Anthony Tabasso
President and CEO
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Company data provided by crunchbase