QA Inspector – 2nd Shift

KVK Tech, Inc.; Newtown (PA); On-site; USD 48,000 - 64,000; Full time

Benefits offered by this job

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

Job summary

KVK Tech, Inc. in Newtown, PA, is seeking a QA Monitor to provide real-time oversight on manufacturing and packaging to ensure products meet cGMP and internal quality standards.

The role supports in-process inspections, documentation review, and deviation identification, collaborating with cross-functional teams in a fast-paced, regulated environment. The ideal candidate has strong attention to detail, effective communication, and the ability to work independently or with others on the

Qualifications

• 0–3 years of QA/QC experience in a cGMP pharmaceutical or other regulated manufacturing environment.
• Working knowledge of FDA, cGMP, and documentation compliance expectations.
• Ability to review and interpret batch records, SOPs, and controlled documents with strong attention to detail.
• Effective communication skills and the ability to work both independently and collaboratively on a production floor.

Responsibilities

• Conduct in‑process inspections, line clearances, and component verifications according to approved SOPs and batch records.
• Review production, packaging, and cleaning documentation for accuracy, completeness, and cGMP compliance prior to QA approval.
• Monitor manufacturing and packaging activities to ensure adherence to established quality standards and to elevate deviations or nonconformances as needed.
• Perform visual and physical inspections of products, components, and labeling to verify conformance with specifications.
• Support deviation investigations, CAPAs, and related quality documentation as directed by QA leadership.
• Ensure data integrity by completing all documentation accurately, contemporaneously, and legibly in alignment with ALCOA+ principles.

Skills

QA/QC experience

Attention to detail

Communication skills

Independent and collaborative work

FDA knowledge

Education

High school diploma or equivalent

Associate degree in science

Job description

KVK Tech is seeking a dedicated QA Monitor to join our team in Newtown, PA.

The QA Inspector provides real‑time oversight on the manufacturing and packaging floors to ensure products meet cGMP requirements, internal quality standards, and applicable regulatory expectations. This role is essential in supporting in‑process inspections, documentation review, and deviation identification, helping maintain product quality and compliance across operations. The ideal candidate will be detail‑oriented, reliable, and capable of collaborating effectively with cross‑functional teams in a fast‑paced, regulated environment.

Responsibilities

• Conduct in‑process inspections, line clearances, and component verifications according to approved SOPs and batch records.
• Review production, packaging, and cleaning documentation for accuracy, completeness, and cGMP compliance prior to QA approval.
• Monitor manufacturing and packaging activities to ensure adherence to established quality standards and to elevate deviations or nonconformances as needed.
• Perform visual and physical inspections of products, components, and labeling to verify conformance with specifications.
• Support deviation investigations, CAPAs, and related quality documentation as directed by QA leadership.
• Ensure data integrity by completing all documentation accurately, contemporaneously, and legibly in alignment with ALCOA+ principles.

Qualifications

• High school diploma or equivalent required; Associate degree in a science discipline preferred.
• 0–3 years of QA/QC experience in a cGMP pharmaceutical or other regulated manufacturing environment.
• Working knowledge of FDA, cGMP, and documentation compliance expectations.
• Ability to review and interpret batch records, SOPs, and controlled documents with strong attention to detail.
• Effective communication skills and the ability to work both independently and collaboratively on a production floor.

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

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.