QA Inspector (7:00am - 3:30pm; Pharma Experience Required)

KVK Tech, Inc.

False Pass (AK)

On-site

USD 52,000 - 62,000

Full time

14 days+

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Benefits offered by this job

Competitive compensation with annual/绩

401(k) with 50% company match

Paid Time Off

Health, dental, vision, life insurance

Career growth opportunities

Professional development reimbursement

Tuition reimbursement for employees'/+

Job summary

KVK Tech is a U.S.-based pharmaceutical manufacturer seeking a QA Inspector to perform in-process and final inspections on production and packaging floors, ensuring products meet quality and regulatory standards.

The ideal candidate will have 1–3 years of QA/QA experience in a GMP setting, a high school diploma or equivalent, strong knowledge of cGMP, documentation practices, ALCOA+ data integrity, and proficiency with Microsoft Office. This is an on-site role with typical daytime hours.

Qualifications

1–3 years QA/Quality Assurance in a GMP environment.
High attention to detail with ability to detect nonconformances.
Proficiency in Office software and documentation systems.

Responsibilities

Perform in-process inspections, verifications, and line clearances per SOPs and batch records.
Monitor manufacturing and packaging operations for cGMP compliance.
Inspect raw materials, in-process samples, finished products, and labeling against specifications.
Review batch production, cleaning, and packaging records for accuracy and completeness.
Document inspection results, deviations, and nonconformances accurately and contemporaneously.
Assist with deviation investigations, CAPAs, and quality event documentation.
Support audits, internal inspections, and continuous improvement initiatives.
Collaborate with Production, Engineering, and Quality teams to address quality concerns promptly.
Maintain data integrity and ALCOA+ documentation at all times.
Perform other QA responsibilities as required.

Skills

cGMP & FDA compliance

Quality inspection techniques

Documentation review

Batch record review

Line clearance

Microsoft Office

Written & verbal communication

Attention to detail

Education

High school diploma or equivalent

AS or coursework in Life Sciences preferred

Job description

Job Description

QA Inspector

About KVK Tech

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

What You’ll Do

The QA Inspector is responsible for performing in-process and final inspections on the production and packaging floors to ensure products meet quality standards and regulatory requirements. This position provides real-time quality oversight, ensuring all operations comply with established procedures, documentation practices, and data integrity expectations.

Key Responsibilities:

Perform in-process inspections, component verifications, and line clearances in accordance with approved SOPs and batch records.
Monitor manufacturing and packaging operations to ensure adherence to cGMP and internal quality procedures.
Inspect raw materials, in-process samples, finished products, and labeling to verify conformance with specifications.
Review batch production, cleaning, and packaging records for accuracy, completeness, and compliance prior to QA release.
Document inspection results, deviations, and nonconformances accurately and contemporaneously.
Assist with deviation investigations, CAPAs, and quality event documentation under QA management direction.
Support audits, internal inspections, and continuous improvement initiatives.
Collaborate closely with Production, Engineering, and Quality departments to address quality concerns promptly.
Maintain data integrity and ensure documentation meets ALCOA+ principles at all times.
Perform other related QA responsibilities as required to meet departmental objectives.

What We’re Looking For

Experience:

1–3 years of Quality Assurance or Quality Control experience in a GMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.

Education:

High school diploma or equivalent required; Associate degree or coursework in Life Sciences, Chemistry, or a related discipline preferred.

Skills & Knowledge:

Strong understanding of current Good Manufacturing Practices (cGMP) and FDA compliance requirements.
Knowledge of quality inspection techniques, sampling methods, and documentation review.
Experience with batch record review, line clearance, or in-process inspection preferred.
High attention to detail with the ability to detect and resolve nonconformances.
Proficiency in Microsoft Office (Word, Excel, Outlook) and standard documentation systems.
Excellent written and verbal communication skills; able to interact effectively across teams.
Strong time-management, organization, and follow-through abilities.
Ability to work independently while maintaining a high standard of accuracy and accountability.

What We Offer

Competitive compensation with annual performance bonus eligibility
Annual merit-based pay increases
Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
Paid Time Off
10 paid company holidays
Comprehensive medical, dental, vision, and life insurance coverage
Career growth opportunities
Professional development reimbursement
Tuition reimbursement for children and childcare expense reimbursement

Schedule