QA Inspector – 1st Shift
KVK Tech, Inc. · Newtown, PA · Today
Quality AssuranceFull-time
About the role
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.
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.
- Maintain quality standards by monitoring manufacturing and packaging activities and escalating deviations or nonconformances as needed.
- 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.
Requirements
- 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.
- Strong attention to detail and ability to review and interpret batch records, SOPs, and controlled documents.
- Effective communication skills and the ability to work both independently and collaboratively on a production floor.
Qualifications
We Are Looking For Applicants With
- A high school diploma or equivalent required; an Associate degree in a science discipline preferred.
- 0–3 years of QA/QC experience in a cGMP pharmaceutical or other regulated manufacturing environment.
- A working knowledge of FDA, cGMP, and documentation compliance expectations.
- A strong attention to detail and ability to review and interpret batch records, SOPs, and controlled documents.
- Effective communication skills and the ability to work both independently and collaboratively on a production floor.
Skills
- Detail-oriented
- Reliable
- Collaborative
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
Pay
N/A
Schedule
N/A